PL245199B1 - Composition to be used to support the body's immunity in the prevention and treatment of Helicobacter pylori infections - Google Patents

Abstract

The subject of the application is a composition containing a mixture of extracts from: thyme (Thymus vulgaris L) with a DER index ranging from 5:1 to 15:1, obtained by water extraction of the above-ground part of this plant; common chamomile (Matricaria recutita) with a DER ranging from 3:1 to 7:1 obtained by water-alcoholic extraction of the flowers of this plant; marjoram (Origanum vulgare) with a DER ranging from 5:1 to 15:1 obtained by water-alcoholic extraction of the above-ground part of this plant; and American cranberries (Vaccinium) with a DER index of not less than 15:1 obtained by water or hydro-alcoholic extraction of the fruits of this plant. The composition is characterized by the fact that it is used to stimulate monocytes to secrete cytokinin IL-10 and to stimulate naturally cytotoxic (NK) cells to secrete cytokinin IL-2. The subject of the application is also a medicinal preparation containing the above composition.

Description

The subject of the invention is a composition containing a mixture of plant extracts to be used to support the body's immunity in the prevention and treatment of Helicobacter pylori infections.

Helicobacter pylori is a gram-negative, oxidase-positive, catalase-positive, curved or spiral rod-shaped bacterium. H. pylori colonizes the gastric mucosa of on average more than half of the world's population. This bacterium causes chronic gastritis, stomach and duodenal ulcers in 10-15% of infected people. Moreover, H. pylori is the etiological factor of gastric cancer and MALT lymphoma, which is why the World Health Organization has classified this microorganism on the list of biological carcinogens. The more frequent occurrence of stomach cancer in people with H. pylori infection was associated with an increased level of immunoglobulin G against H. pylori and active gastritis (A. Nomura et al. in "Helicobacter pylori infection and gastric carcinoma among Japanese Americans in Hawaii') . Chronic inflammation of the gastric mucosa may lead to mutagenesis and thus intensify the carcinogenesis process, similarly to the inflammation in ulcerative colitis, which increases the risk of colorectal cancer.

Therefore, it is important to treat H. pylori infections by completely removing (eradicating) the bacteria present in the gastric mucosa. In the case of peptic ulcer diseases, eradication prevents recurrence of the disease and leads to its permanent cure. Unfortunately, pharmacological treatment of H. pylori infections is long-term and expensive, and is additionally associated with side effects such as: diarrhea, headache, nausea, vomiting, abdominal pain, unpleasant taste in the mouth, constipation, dry mouth, increased thirst, etc. Moreover, in the light of the increasing resistance of H. pylori to antibiotics (in particular to clarithromycin, amoxicillin and metroidazole), treatment is becoming less and less effective. Therefore, it is advisable to look for compositions based on ingredients of natural origin, such as plant extracts or essential oils, in order to treat and prevent diseases caused by H. pylori infection.

Various plant compositions are known, including plant extracts and compositions of various plant extracts, which have medical applications: in H. pylori infections and reducing the risk of H. pylori infection of living organisms, in particular humans.

The use of plants and plant products for their medicinal properties is increasingly used in medicine in the form of the so-called "unconventional therapy". An example of such an alternative therapy is aromatherapy using plant essential oils, assuming that the oils have many effects resulting from the complex nature of their composition. Aromatherapy, despite the fact that it is gaining more and more social acceptance and many people regularly use complementary or homeopathic remedies, is not the only type of unconventional therapy. In the pharmaceutical industry, pharmacological agents and dietary supplements containing plant extracts are widely used.

Plant extracts are liquid, semi-solid or solid preparations obtained from substances of plant origin, such as whole plants or their parts. The extraction process is an operation involving the isolation of an ingredient or mixtures of ingredients using their diffusion into liquids that better dissolve these selected chemical compounds. Additionally, auxiliary substances such as stabilizers and preservatives are optionally added to the extracts. Dry extracts are extracts obtained by additional evaporation of the solvent used for their preparation.

Plant extracts are used as active substances in medicinal compositions and dietary supplements. Depending on the type and content of active compounds, they delay skin aging processes, moisturize, have antibacterial properties, can act as antioxidants, absorb UV radiation, have a whitening effect and help eliminate discolorations, soothe irritations, or stimulate circulation in blood vessels.

It is assumed that for the characterization, i.e. a detailed description of plant extracts, enabling the reproduction of a given plant extract, it is sufficient to indicate the following parameters of the plant extract, the Latin name and the plant part from which the extract was obtained (for example: herb - i.e. the above-ground part of the plant, root or fruit). , solvent used for extraction, DER (Drug Extract Ratio) and, optionally, quantitatively: the content of active substances in this extract. Typically, when characterizing plant extracts, the total composition: quantitative and qualitative of the extract is not provided due to its complexity and, therefore, analytical difficulties in determining it in such detail.

Chamomile is a plant from the Asteraceae family, whose dried baskets are a herbal raw material with medicinal properties. Chamomile contains, among others, flavonoids, coumarins, terpenes, organic acids, choline and mineral salts. A chamomile basket is included in many ready-made preparations, medicinal mixtures and dietary supplements.

Common chamomile has, among others, anti-inflammatory, antispasmodic, wound healing and antibacterial properties. Preparations secreted from chamomile baskets can be used both internally in the case of spasms and inflammation of the stomach and intestines, and externally, for example in inflammation of the skin and mucous membranes, bacterial diseases of the skin and oral cavity, wounds, ulcers and skin allergies.

Thyme is a plant belonging to the Lamiaceae family. Thyme essential oil contains from 20 to 54% of thymol, which is an antiseptic used, among others, as an active ingredient in commercial mouthwashes. Additionally, thyme essential oil contains compounds such as p-cymene, myrcene, borneol and linalool. Before the invention of antibiotics, thyme-based preparations were used, among other things, to combat fungal infections of toenails.

Preparations based on thyme have bactericidal, fungicidal and expectorant properties. They are used for throat ailments such as cough or hoarseness, as well as to stimulate appetite and digestion. The substances contained in thyme leaves also have antioxidant properties.

Common marjoram is a perennial plant belonging to the Lamiaceae family. Origanum essential oil is composed primarily of monoterpenoids and monoterpenes, with the relative concentration of each compound contained within it varying greatly depending on geographic origin and other factors. More than 60 different compounds have been identified, the main ones being carvacrol and thymol. In addition, active ingredients include, for example, tannins, p-cymene, γ-terpinene, caryophylene, spatulenol, germacrene D, β-phenchyl alcohol and δ-terpineol. Common marjoram preparations have expectorant, disinfectant, antidiarrheal, diuretic, antispasmodic, carminative and detoxifying properties. Externally, thymol oil is used for gargling, strengthening baths and to support the healing of skin wounds and itching. An infusion of a mixture of marjoram and other herbs has a carminative effect, so it is used for ailments such as intestinal atony, excessive fermentation in the intestines, flatulence, gastric and duodenal ulcers, and liver hypofunction.

American cranberries belong to the genus Vaccinium. The medicinal properties of cranberries are responsible for, among others: it contains fructose and proanthocyanidins, citric and quinic acid, vitamins A, B1, B2 and C, flavonoids, anthocyanins, flavonols as well as tannins and flavonoid glycosides. Cranberry fruits contain compounds with a unique structure - belonging to flavonols - which are not found in other fruits.

American cranberry fruits and their properties, among others: bactericidal and anti-adhesive, are widely described in scientific literature. The juice from these fruits is traditionally used to prevent and treat urinary tract infections. In addition, the polyphenols contained in cranberries have antioxidant and anti-inflammatory effects, which may be useful in reducing inflammatory processes, including those related to the colonization of pathogenic microorganisms.

Preparations containing, among others, ingredients of natural origin, such as essential oils or plant extracts used for supplementation with active ingredients or treatment of H. pylori infections, are also known from patent literature.

The composition of a dietary supplement containing plant extracts and probiotic microorganisms is known from the European patent application EP1281403. Among the very wide range of plants whose extracts are used according to EP1281403, the following extracts are mentioned: chamomile, thyme and oregano. All of the plants mentioned contain chemical compounds suitable for use in treatment or nutrition. However, in order to intensify the effects caused by these chemical compounds, it is necessary to process (metabolize) them by probiotic microorganisms of the species listed in EP1281403.

From the American patent application US20110159104, a biocompatible microemulsion composition is known, which additionally contains water-soluble and fat-soluble active substances in a stable form. Through microemulsion, the biologically available nutrients associated with honey, preferably together with additional active substances, are introduced by topical application to the skin, orally or intranasally, where they produce positive effects. These emulsions are easy to prepare and can be used in medicine/veterinary medicine, dermatology, and cosmetology. Moreover, microemulsions with honey can be used alone or with substances of appropriate nutritional value in foodstuffs, functional foods, dietary supplements or dietary products.

International patent application WO2016106313 discloses an oral care composition that soothes irritated oral mucosa, stimulates saliva secretion and/or freshens breath. The oral hygiene composition of W02016106313 can also be used for the prevention and treatment of mucositis, gingivitis, periodontitis, dry mouth (xerostomia), oral infections, stomatitis and halitosis. The compositions of W O2016106313 are particularly useful in the treatment of intraoral complications in cancer patients who have undergone chemotherapy or radiotherapy. The composition contains natural ingredients and may be alcohol-free and/or free of artificial colors. The composition according to WO2016106313 has the form of a liquid, gel, powder, paste, film, etc. and contains active ingredients of natural origin. The natural ingredients contained in the composition have antibacterial, anti-inflammatory, soothing, moisturizing properties, etc.

International patent application W O2005087244 discloses compositions containing at least two essential oils derived from plants selected from: Pelargonium; fingerlings; Menta; Aniba; Lavender; Oregano, Litsea; Citrus fruits; Lemon balm; Sandpiper; Sandalwood; Valerian; Styrak; Cinnamon; and Rose, to treat microbial and fungal infections and prevent microbial contamination of surfaces and devices. The compositions may be formulated as drugs, consumer products, or cleaning agents.

Compositions containing glycans and medical foods containing them are known from the international patent application WO2016122889. These compositions also contain microelements, polyphenols, prebiotics, probiotics and other agents. The compositions of WO2016122889 may also be used, among others, to modulate the human gastrointestinal microflora and to treat dysbiosis.

The Polish patent application P.397719 discloses a composition that prevents the development and limits the effects of existing stomach and duodenal ulcers caused by the Helicobacter pylori bacterium and bacterial ulcers of other etiologies, along with stimulating the reconstruction of the gastric mucosa. The composition according to P.397719 contains nanosilica with appropriate properties, optionally with the addition of sodium butyrate and or without other active substances. Nanosilica destroys the walls of bacterial cells, causing them to die. The use of sodium butyrate, the basic energy factor of the gastric and duodenal mucosa cells, an element that strongly stimulates the proliferation of mucosal cells, gives the effect of rebuilding the gastric and duodenal mucosa, which is especially important in places changed by the action of bacteria.

The European patent application EP2133121 discloses a nutritional preparation with cranberry extract containing from 500 to 2500 mg of cranberry powder for preventive or therapeutic use in recurrent stomach ailments. The preparation, apart from cranberry extract, may contain: chicory inulin, zinc gluconate, lactose, raspberry flavor. The preparation can be used to help eliminate H. pylori from the digestive system.

The Polish patent application PL366161 discloses a nutritional composition containing essential oils for preventive and therapeutic use in infections caused by organisms from the Helicobacter family.

European patent application EP0577481 discloses the use of thyme extract (Latin: Thymus) and its aqueous solutions to inhibit the growth of H. pylori bacteria in humans. The extract can be administered orally in the form of a drink, capsules or paste, or used to prepare a pharmaceutical composition that inhibits the activity of the enzyme: urease of H. pylori bacteria cells.

The European patent application EP2604273 discloses a composition with a therapeutic effect in various bacterial infections, in particular those caused by Staphylococcus aureus, containing marjoram extract and at least one additional extract from plants from the Rosaceae, Umbellate and Asteraceae families.

International patent application WO0115680 discloses a composition for use in the treatment of infections in humans and animals containing an antibacterial ingredient: isopropyl-o-cresol, extracted from a plant from the Lamiaceae or Verbenaceae group.

Furthermore, in Cogo L.L. "Anti-Helicobacter pylori activity of plant extracts traditionally used for the treatment of castrointestinal disorders" Brazilian Journal of Microbiology (2010) 41: 304-309, ISSN: 1517-8382 describes the use of extracts of the following plants in the treatment of H. pylori infections: arnota proper, common chamomile, holly, common plantain, wood mallow, rhubarb. The tests carried out showed the highest anti-H. pylori activity of extracts from chamomile and holly. In the tests performed, the effect of the above extracts on supporting the activity of monocytes and cytotoxic cells of living organisms, including humans, was not examined.

There is also a known herbal mixture, available under the trade name: Helicobacter Pylori Mixture by Ziółko (Łopiennik Górny, Poland), containing: chamomile flower Chamomilla recutita L., peppermint leaf Mentha piperita L., common thyme leaf Thymus vulgaris L., purple coneflower herb Echinacea purpura L - in the form of dried, crushed plant parts, for infusion. However, for the indicated mixture there is no information about the content of individual herbs in the mixture, and there is no information about its effect supporting the activity of monocytes and naturally cytotoxic cells. Moreover, there is no information on the manufacturer's website or on the packaging that this mixture has a medical effect in combating or preventing H. pylori infections, because the "Helicobacter Pylon" family of bacteria indicated in the product name does not specifically refer to the medicinal use of this composition. Therefore - solely on the basis of the information disclosed about the mixture and its availability, it would not be possible to simultaneously determine the composition of this mixture (percentage content of its individual ingredients) and whether this composition has an effect supporting the activity of monocytes and naturally cytotoxic cells, and therefore including supporting the body in infections and preventing H. pylori infections.

Moreover, the publication by M. Habuz "Alternative substances in the eradication treatment of Helicobacter Pylori Articles - Biotechnologia.pl (editor's office: February 6, 2014) describes groups of synthetic drugs that can be used in the treatment of H. pylori infection, including: xanthone derivatives: substituted with a chlorine atom in position 2, and 3 and 4, phenolic derivatives: derivatives of cinnamic acid, derivatives of gallic acid, oleuropein, rutin or quercetin. The publication also indicates the following compounds: cinnamal acid and cinnamaldehyde, eugenol, coumarin isolated from the Chinese cinnamon tree, and lists plant extracts, including: Chinese tea extract, as well as a water extract of licorice smooth for use in the prevention and treatment of gastric and duodenal ulcers. The publication also indicates the possibility of combined action of oregano and cranberry extracts in combating H. pylori, for a composition containing 25% oregano extract and 75% cranberry extract, and describes the effect of red wine in the mechanism of inactivation of the H. pylori VacA cytotoxin. However, this publication lacks more detailed data on the composition of such compositions.

However, in the publication of H.Sakkas, Ch. Papadopoulou "Antimicrobial Activity of Basil, Oregano, and Thyme Essential Oils" J. Microbiol. Biotechnol. (2017), 27(3), 429-438, the independent action of individual essential oils of basil, oregano and thyme was described. This publication indicates the antibacterial and antifungal effects of essential oils obtained from the above-mentioned plants, but does not describe or suggest the possibility of the action of these essential oils: basil, oregano and thyme in relation to the activity of monocytes and naturally cytotoxic cells of the immune system.

A particularly important aspect of Helicobacter pylori infections is their immunomodulatory activity towards immune cells, such as macrophages, naturally cytotoxic (NK) cells and lymphocytes. Thanks to this, H. pylori can survive in the colonized gastric mucosa and be resistant to its control for many years. Particular attention should be paid to NK cells because they do not require activation to attack cells that lack the expression of MHC molecules. This is particularly important because harmful cells that lack the expression of MHC molecules cannot be detected and destroyed by other cells of the immune system, such as T lymphocytes. NK cells come from the bone marrow, and unlike T and B lymphocytes, their differentiation and rearrangement functions genes is not necessary. NK cells play an important role in initiating the immune response, primarily by the rapid secretion of interferon γ (IFN-γ) and other cytokines necessary in response to bacterial, viral and parasitological infections, constituting the first line of defense, together with monocytes, against cancer cells and viral infections, acting as a key role in stopping the development of infection. They do not express conventional antigen receptors, such as superficial immunoglobulins or antigen-binding receptors on T cells.

As shown in the publication "Helicobacter pylori-driven modulation of NK cell expansion, intracellular cytokine expression and cytotoxic activity" (Karolina Rudnicka, Magdalena Chmielą et al., Innate Immunity 2015, Vol. 21(2) 127-139), Natural Killer cells may be involved in the immune response to combat Helicobacter pylori infection. Additionally, it was shown that the blood of donors infected with H. pylori was dominated by NK cells with lower cytotoxic activity compared to the blood of donors with excluded H. pylori infection. This may be due to the dominance of NK cells with the CD56 ^bright phenotype, characterized by weak cytotoxic properties in donors infected with H. pylori, as well as the influence of regulatory IL-10. The serum concentration of this cytokine was higher in H. pylori-infected donors than in uninfected donors. It has also been shown that the response of NK cells to Helicobacter pylori depends on the type of antigen challenge. It can be modulated positively by H. pylori GE via IFN-γ and IL-2 or negatively by H. pylori LPS via IL-10. It is possible that in people infected with Helicobacter pylori, antigens with negative immunomodulatory potential, such as lipopolysaccharide (LPS), may inhibit immune reactions and weaken the elimination of Helicobacter pylori from the gastric mucosa, which consequently promotes the development of a chronic form of the infection.

Another problem related to H. pylori infections is the increasing antibiotic resistance of these microorganisms. The percentage of Helicobacter pylori strains resistant to clarithromycin and failure to eradicate the first treatment regimen (proton pump inhibitor, amoxicillin and clarithromycin) has increased in Japan as well as in other countries.

Therefore, factors such as the high prevalence of H. pylori in the population, the variable effectiveness of treatment and its high costs, and the fact that asymptomatic people cannot be treated with antibiotics make it an important aspect of research to search for alternative solutions capable of interfering with the action of H. pylori in high-risk populations.

Therefore, there is a need to develop an alternative composition containing an appropriate combination of plant extracts to strengthen the first line of the body's immune defense, i.e. monocytes and Natural Killer (NK) cells, which could be used especially to increase the body's overall immunity and support the treatment of Helicobacter pylori infections.

The subject of the invention is a composition containing a mixture of extracts from:

- thyme (Thymus vulgaris L.) with a DER of 10:1 obtained by water extraction of the above-ground part of this plant;

- common chamomile (Matricaria recutita) with a DER of 4:1 obtained by water-alcoholic extraction of the flowers of this plant, with a water-alcohol volume (v:v) of 1:1;

- marjoram (Origanum vulgare) with a DER of 5:1 obtained by water-alcoholic extraction of the above-ground part of this plant, with a water-alcohol volume (v:v) of 1:1; and

- American cranberries (Vaccinium) with a DER of 18:1 obtained by water extraction of the fruits of this plant;

characterized by the fact that the extracts in the mixture are in the proportions of thyme extract: common chamomile extract: marjoram extract: cranberry extract of 100: 12.5: 6.25: 100, to be used to support the body's immunity in prevention and treatment of Helicobacter pylori infections.

Preferably, the composition contains American cranberry extract at a concentration of 6.5 μg/ml to 50 μg/ml. Preferably, the extracts are included in the composition in liquid, semi-solid or solid form.

Preferably, the composition is administered in the form of tablets, capsules, sachets, suspension, gel or syrup.

Preferably, the composition additionally contains probiotics.

Preferably, the composition further comprises beta-glucan.

Preferably, the composition additionally contains cistus extract.

Preferably, the composition is taken in a dose containing 100 mg of thyme extract, 12.5 mg of common chamomile extract, 6.25 mg of marjoram extract and 100 mg of American cranberry extract.

Preferably, a single dose of the composition is taken twice daily before meals.

Preferably, a double dose of the composition is taken once daily before a meal.

Definitions used in this description:

By the term "medical use" of a composition according to the present description is meant the use of this composition in the treatment and prevention of disease(s), infection, disease(s) or ailment.

The above term "treatment" is understood to mean a series of actions leading to the removal or alleviation/limitation, or stopping at the current stage or slowing down the progression of symptoms, effects and/or manifestations of the disease/diseases, disease/diseases or ailments.

The above term "prevention" is understood to mean a series of activities aimed at preventing or reducing the risk of disease/diseases, infections, illness/diseases or ailments.

Accordingly, the term "medical use" of a composition as described herein includes:

- preventing disease/diseases, infections, illness/diseases or ailments, and

- reducing the risk of disease(s), infection, disease(s) or ailments.

Moreover, the DER ratio of the plant extract (Drug Extract Ratio) is understood as the ratio of the amount of plant raw material (A) to the amount of the obtained plant product (B); written as A:B. Its purpose is to enable comparison of plant extracts containing the same substance but obtained in different ways (e.g. extracts with different degrees of concentration).

For example, a DER of 10:1 means that ten parts of the plant yield one part of the extract.

The subject of the present invention is a composition containing a mixture of extracts from chamomile, thyme, common marjoram and cranberry, combined in appropriate proportions, strengthening the first line of the body's immune defense, i.e. supporting the activity of monocytes and Natural Killer (NK) cells, which is particularly useful in supporting the treatment and prevention of Helicobacter pylori infections.

The subject of the invention is presented in the drawing, in which Fig. 1 shows the stimulation of THP1XBIue™ monocytes after a 4-hour incubation with plant extracts or a control stimulator (LPS E. coli), Fig. 2 shows the stimulation of THP1XBIue™ monocytes after a 24-hour incubation with plant extracts or control stimulator (LPS E. coli), and Fig. 3 shows the stimulation of THP1XBIue™ monocytes after 72 hours of incubation with plant extracts or control stimulator (LPS E. coli).

The darkest bars are the highest concentration, intermediate bars are the intermediate concentration, and the lightest bars are the lowest concentrations, in accordance with Table 3. The so-called horizontal line the cut-off value is twice the negative control (cells in culture medium without a stimulator).

The base composition according to the invention is a mixture of extracts from common chamomile, thyme, common marjoram and American cranberries in the proportion of thyme extract: common chamomile: common marjoram: American cranberries: from 14 to 20: from 1 to 5: from 1 to 3 : from 3 to 8 p.m.

The extracts used to prepare the compositions according to the invention are obtained by standard methods known in the art, by extracting the whole plant or its part with a selected solvent, for example: water, ethyl alcohol, glycerol or oil. Extraction occurs as a result of contact of the plant material with a solvent, and the longer the contact time, the higher the content of extracted plant substances in the obtained extract, and therefore the higher the DER index of the extract.

The developed selection of a group of plants: common chamomile, thyme, common marjoram and American cranberry ensures the effect of the composition, manifested by the stimulation of appropriate monocytes and naturally cytotoxic cells in the body, with the most advantageous use of the following plant extracts in the composition according to the invention, in the case of which a certain minimum content of essential oils and/or other active substances listed below is important:

- aqueous thyme extract (Thymus vulgaris L), part of the plant used for extraction: herb; extracts with a DER of 5:1 to 15:1 are preferably used, an example extract may contain essential oils in an amount of not less than 1% and rosmarinic acid in an amount of not less than 0.5%;

- hydro-alcoholic extract of oregano (Origanum vulgare) (volume content of part of water and part of alcohol ranging from 9:1 to 1:9), part of the plant used for extraction: herb, preferably extracts with a DER index of 5 are used: 1 to 15, an exemplary extract may contain essential oils in an amount not less than: 2%;

- aqueous or water-alcoholic cranberry extract (volume content of part of water and part of alcohol, for the water-alcoholic extract in the range from 9:1 to 1:9), part of the plant used for extraction: fruit; extracts with a DER index of at least 15:1 are preferably used, which means that it is possible to use extracts with a DER index of, for example: 15:1, 16:1, 17:1, 18:1, 19:1, or 20:1, or for example 25: 1, an exemplary extract may contain proanthocyanidins in an amount of not less than 20%;

- hydro-alcoholic chamomile extract (Matricaria recutita) (volume content of part of water and part of alcohol ranging from 9:1 to 1:9), part of the plant used for extraction: flower; extracts with a DER index ranging from 3: 1 to 7: 1 are preferably used, an example extract may contain essential oils in an amount of not less than: 0.4%.

An exemplary thyme extract that can be used to implement the invention is characterized by a DER index of 7:1 and an essential oil content of approximately 1.6% by weight. An example of common chamomile extract that can be used to implement the invention is characterized by a DER index of 7:1 and an essential oil content of approx. 0.7% by weight. An exemplary marjoram extract that can be used to implement the invention is characterized by a DER index of 10:1 and an essential oil content of approximately 2% by weight. An exemplary extract from American cranberries that can be used to implement the invention is characterized by a high content of proanthocyanins, min. 20%. Other extracts obtained from the plants indicated above can also be used, with equivalent contents of active substances, and therefore with DER indicators within the ranges indicated above.

The combination of plant extracts from: thyme, oregano, cranberry and chamomile in the above-mentioned proportions allows you to obtain a base composition with properties supporting the activity of monocytes and natural killer cells, through appropriate stimulation of these cells, and this stimulation is characterized in the test results below: Example 3.

Moreover, the composition of plant extracts according to the invention is characterized by a twice stronger bactericidal effect (MBC) than in the case of each of the above-mentioned extracts used individually, which was confirmed by the tests, the results of which are summarized below.

Moreover, the bacteriostatic effect (MIC) of thyme extract is stronger in a mixture with oregano, cranberry and thyme extract than when the thyme extract is used individually due to the synergistic effect, which was confirmed by tests whose results are summarized in Table 2 presented below for example 2 .

As shown by the research presented in examples 3, 4 and 5, the developed composition of plant extracts can also be used to prevent and support resistance to colonization of the gastric mucosa by Helicobacter pylori bacteria - by strengthening the first line of the body's immune defense, i.e. monocytes and Natural Killer (NK) cells. ), because the developed composition of plant extracts, as indicated above, ensures appropriate stimulation of these cells in the body - and therefore the developed composition can be used for medical purposes - in the prevention of H. pylori infections.

Helicobacter pylori structures weaken the activity of monocytic cells and the cytotoxic activity of NK cells in terms of their ability to secrete cytokines, which are mediators that stimulate the action of other immune cells, inhibit their ability to absorb and kill intracellular bacteria, and also inhibit their recognition of Helicobacter pylori antigens.

The composition of plant extracts according to the invention stimulates monocytes, and their stimulation is associated with the secretion of cytokines, which proves that these cells become more effective in fighting infections, including those caused by H. pylori, which additionally confirms the possibility of medical use of this composition both in the treatment of as well as in the prevention of H. pylori infections, by supporting the activity of monocytes and naturally cytotoxic cells, manifested by their appropriate stimulation.

Additionally, the cranberry extract contained in the composition according to the invention has an effect that is manifested by an increase in the percentage of stimulated NK cells expressing the receptor.

CD25, which may be equivalent to an increase in their cytotoxic activity against Helicobacter pylori.

The composition of plant extracts according to the invention may also contain additional ingredients, such as probiotics, beta-glucan, Fenugreek, Bilberry, Dandelion, Angelica, Centella Asiatica, Horse chestnut, Cistus laurel.

The composition of plant extracts according to the invention may also contain a number of technological substances, for example calcium carbonate; titanium dioxide; iron oxides and hydroxides; aluminum; sorbitols, mannitol, acesulfame K, aspartame, cyclamates, isomalt, saccharins, sucralose, neohesperidin DC, aspartame and acesulfame salt, maltitols, lactitol, xylitol, erythritol, sorbic acid, potassium sorbate, benzoic acid, sodium benzoate, potassium benzoate, benzoin an calcium , ethyl p-hydroxybenzoate, sodium ethyl p-hydroxybenzoate, methyl p-hydroxybenzoate, sodium methyl p-hydroxybenzoate, acetic acid, potassium acetate, calcium acetate, lactic acid, malic acid, ascorbic acid, sodium ascorbate, calcium ascorbate, mixture tocopherols, alpha-tocopherol, lecithins, sodium lactate, potassium lactate, calcium lactate, citric acid, sodium citrates, potassium citrates, calcium citrates, tartaric acid (L(+)-), potassium tartrates, phosphoric acid, potassium malate, calcium tartrate , rosemary extracts (rosemary extracts), alginic acid, sodium alginate, potassium alginate, calcium alginate, processed Eucheuma seaweed, guar gum, tragacanth, gum arabic (acacia gum), xanthan gum, gellan gum, glycerol, konjac , polyoxyethylene sorbitan monooleate (polysorbate 80), pectins, cellulose, methylcellulose, ethylcellulose, hydroxypropylcellulose, cross-linked sodium carboxymethylcellulose, sodium, potassium and calcium salts of fatty acids, magnesium salts of fatty acids, sodium carbonates, potassium carbonates, magnesium carbonates, hydrochloric acid (acid hydrochloric acid), sodium hydroxide, potassium hydroxide, calcium hydroxide, calcium oxide, magnesium oxide, silicon dioxide, calcium silicate, magnesium silicate, talc, l-cysteine, polydextrose, polyvinylpyrrolidone, polyvinylpolypyrrolidone, polyvinyl alcohol (PVA), pullulan, oxidized starch, glycerol diacetate (diacetin), glyceryl triacetate (triacetin), propane-1,2-diol (propylene glycol), polyethylene glycol.

The composition of plant extracts according to the invention is administered orally and may take any form, for example tablets, capsules, sachets, suspension, gel, syrup, etc.

The composition of plant extracts according to the invention therefore has medical applications, in particular in the treatment and therapeutic treatment including not only the treatment of sick people - i.e. infected with H. pylori, but also including prophylactic administration of the composition of plant extracts according to the invention to healthy people, in order to support the activity of monocytes and cytotoxic cells - by stimulating these cells in the person who took the preparation, thus reducing the risk of infection with the H. pylori bacterium. It should be noted that each dose of the composition according to the invention used prophylactically - in a healthy person, is also a medical use of the composition according to the invention, because it has a stimulating effect on monocytes and naturally cytotoxic cells, thus reducing the risk of H. pylori infection - in accordance with the mechanism of action of the composition described above.

Therefore, the medical use of the developed composition of plant extracts in healthy people, i.e. not infected with H. pylori, involves reducing the risk of infection with this bacterium, or making the H. pylori infection less severe in the event of its occurrence, including: protection against various diseases. diseases caused by H. pylori infection, as well as the occurrence of various diseases and/or ailments that may accompany or be a consequence of H. pylori infections, for example: diseases of the upper gastrointestinal tract, including: gastritis, gastric ulcer and /or duodenum, stomach cancer or lymphoma. Among other things, H. pylori infection may cause inflammation of the mucous membrane, which is initially acute and then becomes chronic. In some infected people, there may be a secondary increase in the production of stomach acid, which has a direct ulcerogenic effect. However, both preventive (in a person not infected with H. pylon) and therapeutic (in a person infected with H. pylon) use of the composition according to the invention will each time reduce the risk of the above diseases/ailments.

The composition of herbal extracts according to the invention can also be used in cases of H. pylori infection in order to reduce the unfavorable symptoms/ailments accompanying H. pylori infection for the patient, such as: constipation, loss of appetite, abdominal pain, epigastric pain, nausea, heartburn, belching or flatulence. .

PL 245199 Β1

The developed composition of plant extracts according to the invention containing extracts from: common chamomile, thyme, common marjoram and American cranberries in the proportion of thyme extract: common chamomile: common marjoram: American cranberries of: 100: 12.5: 6.25: 100 shows therefore, the action involves appropriate stimulation of the body's immune cells: monocytes and naturally cytotoxic cells, resulting in the improvement of the body's immunity towards not only fighting, but also preventing H. pylori infections. This is due to the fact that the body with stimulated appropriate cells of the immune system - as indicated above - not only shows an increased tendency to fight H. pylori - in the case of already infected people, but also shows a reduced risk of H. pylori infection - in the case of healthy people. : i.e. people who have never been infected and people who have been infected with H. pylori in the past and are therefore more vulnerable to re-infection. The medical effect of the above composition is observed regardless of the value of the DER indicators of the plant extracts used to prepare the composition according to the invention, which may be due to the fact that the composition of the above herbs itself has an effect on stimulating the appropriate cells of the immune system.

However, the most beneficial effect of the above composition is observed for the following extracts: aqueous thyme extract (plant part: herb) with a DER of 10:1, aqueous-alcoholic marjoram extract (plant part: herb) with a DER of 5:1 , aqueous cranberry fruit extract with a DER of 18:1 and aqueous-alcoholic chamomile flower extract with a DER of 4:1.

In order to determine the stimulating effect of the compositions, various extracts and their compositions were tested, and the most important of these tests are discussed in the examples below.

EXAMPLE 1: Dosage of the composition

The composition of plant extracts according to the invention is administered twice a day in a single dose before a meal or once a day in the morning before a meal in a double dose in order to obtain the desired effects.

A single dose of the base composition contains the following amounts of extracts:

Table 1: Content of extracts in one dose of the base composition

Extract [mg/dose] Thyme (water extract), DER: 10:1 100 Common chamomile (water-alcoholic extract v:v = 1:1, DER: 4:1) 12.5 Common marjoram (common name: oregano) (water-alcoholic extract v:v = 1:1, DER: 5:1 6.25 American cranberry (water extract, DER: 18:1) 100

EXAMPLE 2: Test results of the composition in terms of antimicrobial activity against Helicobacter pylori bacilli

Table 2: Antimicrobial activity of the composition against Helicobacterpylori

Extract MIC [pg/ml] MBC [pg/ml] Tolerance Common chamomile 3.12 6.25 2 Thyme 6.25 6.25 1 Marjoram 3.12 6.25 2 A mixture of the above 3.12 3.12 1

As shown in Table 2, plant extracts from chamomile, marjoram and thyme used together have twice the bactericidal effect (MBC) than extracts used individually. Moreover, the bacteriostatic effect (MIC) of thyme extract is stronger in a mixture than when used individually. It follows that the base composition has a synergistic effect. The test was carried out for a composition containing a mixture of extracts from thyme, common chamomile and marjoram in a ratio of 16:2:1. A synergistic effect, consisting in a stronger bactericidal effect in relation to individual extracts and a stronger bacteriostatic effect of the thyme extract, was also found for other mixtures, in proportions from 14 to 20: from 1 to 5: from 1 to 3.

EXAMPLE 3: Testing the activity of plant extracts in terms of stimulating monocytes of the THP1XBIue™ line

In the first stage of testing plant extracts for their potential to stimulate monocytes of the THP1XBIue™ line, the following was demonstrated:

- Thyme extract at a concentration of 50 μg/ml significantly stimulated (activated nuclear factor NFKB) cells of the THP-1 XBIue™ line compared to unstimulated cells (p=0.002);

- Common chamomile and marjoram extracts did not cause activation of THP1 XBIue™ line cells compared to unstimulated cells;

- The mixture of extracts according to the tested solution stimulates THP1XBIue™ cells statistically significantly more strongly than cells stimulated with chamomile and marjoram extract at p=0.002;

- A mixture of thyme, common chamomile and marjoram extracts statistically significantly stimulates THP1XBIue™ cells compared to unstimulated cells (p=0.001).

It can be suggested that the effect of stimulating THP1XBIue™ cells in cultures treated with the mixture of extracts depends on the thyme extract contained in it, and therefore the studies confirmed the validity of using this extract in the composition.

In the next stage, it was examined whether the mixture of plant extracts and plant extracts used separately stimulate peripheral blood monocytes to secrete pro-inflammatory cytokines: tumor necrosis factor TNF-α and/or anti-inflammatory cytokines: interleukin IL-(10). Testing of plant extracts for their potential to stimulate peripheral blood monocytes to secrete cytokines showed that:

- Thyme extract at a concentration of 50 μg/ml significantly stimulated peripheral blood monocytes to produce the pro-inflammatory cytokine TNF-α (p=0.05) and the anti-inflammatory cytokine IL-10 (p=0.05), compared to unstimulated culture;

- The mixture of extracts according to the invention statistically significantly increased the secretion of IL-10 and TNF-α by peripheral blood monocytes, compared to the concentration of these cytokines in cultures treated with chamomile extract (p=0.05) or marjoram (p=0.05). ) used separately;

- The mixture of extracts according to the invention statistically significantly increased the secretion of TNF-α and IL-10 by peripheral blood monocytes compared to the concentration of these cytokines in unstimulated cultures (p=0.05).

EXAMPLE 4: Immunostimulation test with plant extracts and known bacterial stimulants for a period of 4 hours, 24 hours. and 72 hours

20 μl of the tested plant extracts were added to the cells in order to finally obtain the concentrations selected at the earlier stages in the wells (Table 3). The following methodology for dissolving the extracts was used: (1 mg/ml): extracts from common chamomile, thyme and cistus were dissolved in the cRPMI medium alone, the Usnea lichen extract in 100% DMSO, and the rest of the plant extracts in 10% DMSO in cRPMI. Further dilutions of the extracts were made in cRPMI culture medium and then filtered through 0.22 μm filters. Ultimately, three concentrations were used in the study for each of the tested plant extracts (Table 3), including negative controls; wells with cRPMI culture medium only; wells containing THP1XBIue™ cells in cRPMI medium and controls of the solvents used, i.e. THP1XBIue cells in appropriate concentrations of DMSO, as well as a positive control known monocyte stimulator - E. coli LPS at a concentration of 1 μg/ml.

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Table 3: Plant extracts and their concentrations and solvents selected for immunomodulation studies

Extract Solvent used Concentrations [pg/ml] American cranberry 10% DMSOwcRPMI 50 6.25 3.125 Common chamomile cRPMI 25 6.25 3.125 Thyme cRPMI 50 6.25 3.125 Laurel leaf cistus cRPMI 50 6.25 3.125 Licorice 10% DMSOwcRPMI 50 6.25 3.125 Brodaczka lichen 100% DMSO 6.25 3.125 0.025 Marjoram 10% DMSOwcRPMI 50 6.25 3.125

After 4 hours, 24 hours or 72 hours, 96-well plates with cell cultures treated with plant extracts were centrifuged at 1400 rpm for 10 min. and then 20 pl of culture supernatant were collected from each well and transferred to a separate plate containing the OuantiBlue detection reagent (Invivogen). After 3 hours, the absorbance was measured at a wavelength of 620 nm using a ThermoScientific Multiscan Go reader.

As shown in Fig. 1.4-hour incubation of monocytes, both with all types of plant extracts at all concentrations according to Table 3, and with the E. coli LPS control preparation did not lead to the activation of such cells, and therefore the absorbance values remained at the level of the untreated culture . Four-hour exposure of monocytes to plant extracts and a control stimulator was insufficient.

As shown in Fig. 2, 24-hour incubation of monocytes with the E. coli LPS control preparation led to strong stimulation of such cells, which was manifested by an increase in the absorbance value (OD620nm) to 1.250. Taking into account the cut-off value of 0.410, thyme extract at the highest concentration used (50 pg/ml) significantly stimulated monocytes, compared to the untreated culture. This effect was not observed for other tested plant extracts.

As shown in Fig. 3, 72-hour incubation in a control stimulator environment (LPS E. coli), the level of TFIP1 XBIue™ monocyte stimulation decreased by almost half to a value of 0.7. The level of activation caused by thyme extract at a concentration of 50 pg/ml remained above the cut-off level, but decreased by 20% to 0.450. Incubation extension to 72 hours caused increased stimulation of monocytes cultured in the environment of common chamomile and cistus at a concentration of 6.25 pg/ml.

Then, in order to investigate whether monocyte activation is associated with the production of pro- or anti-inflammatory cytokines, with the consent of the Local Ethics Committee, monocytes isolated from the peripheral blood of healthy donors were stimulated with thyme extract: 50 pg/ml for 24 hours, common chamomile or cistus laurel extract. 6.25 pg/ml for 72 hours, including the untreated control and LPS-treated E. coli, and then the culture supernatants were tested for the presence of TNF-a or IL-10 in ELISA enzyme-linked immunosorbent assays.

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Table 4: Concentration of TNF-α (a) and IL-10 (b) after 24 or 72 hours of stimulation of peripheral monocytes from healthy donors with excluded H. pylori infection with plant extracts

a) TNF-α [pg/ml] Unstimulated. Thyme [50pg/ml] Common chamomile [6.25pg/ml] Laurel leaf cistus [6.25pg/ml] DMSO 10% E. coli LPS [1 pg/ml] 24 hours 0 0 n.b n.b n.b 23.9 72 hours 0 0 0 0 0 0 b) IL-10 [pg/ml] Unstimulated. Thyme [50pg/ml] Common chamomile [6.25pg/ml] Laurel leaf cistus [6.25pg/ml] DMSO 10% E. coli LPS [1 pg/ml] 24 hours 0 47.7 n.b n.b n.b 91.8 72 hours 0 31.7 0 0 0 76.4

In the supernatants from cultures not treated with stimulating factors and in cultures treated with diluent (DMSO/cRPMI), the presence of none of the tested cytokines was detected. However, it was observed that stimulation of THP1 XBIue™ cells by thyme extract (50 pg/ml) was accompanied by the secretion of immunoregulatory IL-10 (Table 4b). This effect was observed both after 24 and 72 hours. stimulation. Thyme extract did not stimulate such cells to secrete the pro-inflammatory factor TNF-α, a cytokine associated with an unfavorable, excessive inflammatory response (Table 4a). For comparison, LPS E. coli - a bacterial component that stimulates monocytes to a pathological inflammatory reaction (observed, e.g. in the course of sepsis) stimulated monocytes to secrete both IL-10 and TNF-μ factor. In response to chamomile and cistus extracts, monocytes did not secrete any of the tested cytokines (Table 4a, 4b).

To summarize the research results: the plant extract with the highest immunomodulatory potential is thyme extract, which at the highest safe in vitro concentration after 24 hours of stimulation caused significant stimulation of THP1XBIue™ monocytes, in relation to unstimulated culture (p<0.05). Common chamomile and cistus extracts stimulated the activity of monocytes of the THP1XBIue™ line, only after a 72-hour exposure at a concentration of 6.25 pg/ml, i.e. a dose defined as antimicrobial against H. pylori bacilli, but this stimulation was not associated with an increase in activity cytokine response of peripheral monocytes in the production of IL-10 or TNF-α. An important aspect is that the effect of the above plant extracts in terms of stimulating monocytes of the THP1XBIue™ line can be described as moderately strong, because it is half of the range induced by the control factor - E. coli LPS. This is a desirable feature in the case of substances with immunoprotective potential, as excessive immunostimulation could lead to an undesirable inflammatory reaction.

Stimulation of monocytes to produce IL-10 in the absence of TNF-α is an advantage of thyme extract, because IL-10 is a factor that inhibits the production of pro-inflammatory cytokines such as TNF-α, IL-2, or IFN-γ, the increased production of which is observed in chronic inflammation, intestinal inflammation or autoimmune diseases.

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EXAMPLE 5: Study of the effect of extracts of plant origin on the cytotoxic, secretory and phenotypic activity of peripheral NK cells from healthy donors.

Peripheral blood was collected with the consent of the bioethics committee of the University of Lodz, from healthy donors selected from among the employees of the Faculty of Biology and Environmental Protection. Previously, donors were tested for the presence of serum antibodies against H. pylori and subjected to a urea breath test. In all donors included in the study, H. pylori infection was excluded based on negative results of both tests. Each time, peripheral blood was collected in a room designated for this purpose, by a person with appropriate qualifications. The blood was layered on the monocytic-lymphocyte fraction isolation medium in a 1:1 ratio and then centrifuged at 1400 rpm for 30 minutes. After centrifugation, the lymphocyte-monocytic fraction was obtained, washed twice with culture medium, and the density of the suspension was calculated, bringing it to ^2x107 cells/ml. The cell suspension prepared in this way was then applied to the wells of a 24-well vessel and subjected to a 90-minute incubation. After this time, the non-adherent lymphocytic fraction was recovered and subjected to 24-hour stimulation with plant extracts presented in Table 5. A negative control (unstimulated culture) and a positive control (cells stimulated with E. coli LPS) were also included.

Table 5: Plant extracts and their concentrations selected for immunomodulation studies in the field of activation, phenotyping and secretory activity of peripheral NK cells.

Extract Concentrations [pg/ml] American cranberries 50 6.25 3.125 Common chamomile 25 6.25 3.125 Thyme 50 6.25 3.125 Laurel leaf cistus 50 6.25 3.125 Licorice 50 6.25 3.125 Oregano 50 6.25 3.125 Usnea lichen 6.25 3.125 0.02

After stimulation, the non-adherent fraction containing lymphocytes, including NK cells, was collected in separate test tubes (protecting the supernatants, which were used in the next step to assess the secretory activity in response to plant extracts), and subjected to labeling of NK cell surface markers with monoclonal antibodies (mAb) conjugated with fluorescent labels: anti-CD3-FITC mAb; anti-CD56-PE mAb; Anti-CD25-APC mAb. The above labeling of surface markers and cytometric analysis of the results were performed using FlowJo software and allowed for the calculation of the percentages of NK cells (CD3 CD56 ⁺ ) and activated NK cells (CD3 CD56 ⁺ CD25 ⁺ ).

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Table 6: Effect of plant extracts on the number and phenotype of peripheral NK cells determined by surface receptor immunophenotyping and flow cytometer analysis

Concentration [pg/mi] NK Statistical significance Activated NK cells Statistical significance CD3+CD56+ p with respect to control uncomfortable with my loved one %CD25+ p with respect to control unstimulated Thyme 50 18/01 p>0.05 0.75 p>0.05 6.25 17.92 p>0.05 1.00 p>0.05 3.125 10.04 p>0.05 1.10 p>0.05 Common chamomile 25 35.17 p<0.05 1.23 p<0.05 6.25 26.38 p<0.05 1.40 p<0.05 3.125 13.70 p>0.05 0.48 p>0.05 American cranberries 50 25.56 p<0.05 2.24 p<0.05 6.25 27.96 p<0.05 1.78 p<0.05 3.125 11.37 p>0.05 0.85 p>0.05 Tauroleaf cistus 50 30.46 p<0.05 0.86 p>0.05 6.25 20.28 p>0.05 1.10 p>0.05 3.125 13.15 p>0.05 0.98 p>0.05 Licorice 50 24.57 p>0.05 0.61 p>0.05 6.25 17.95 p>0.05 0.47 p>0.05 3.125 13.41 p>0.05 1.00 p>0.05 Oregano 50 24.66 p<0.05 1.06 p>0.05 6.25 18/09 p>0.05 1.28 p>0.05 3.125 11.65 p>0.05 0.91 p>0.05 Lichen Usnea 3.25 25.62 p>0.05 0.98 p>0.05 3.125 19.00 p>0.05 1.11 p>0.05 0.02 12.41 p>0.05 1.03 p>0.05 Com. Unfortunate. RPMI 18.05 - 0.98 E. coli LPS 1pg/ml 25.73 p<0.05 j 2:90 p<0.05

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As shown in Table 6, cranberry extract at concentrations of 50 and 6.25 pg/ml, common chamomile extract at concentrations of 25 and 6.25 pg/ml and extracts of cistus laurel and marjoram at concentrations of 50 pg/ml caused a significant increase in the percentage of NK cells with the phenotype (CD3 CD56 ⁺ ), compared to unstimulated culture. The observed increase in the number of such cells may indicate stimulation of proliferation, i.e. an increase in the number of cells belonging to this population. Moreover, in lymphocyte cultures treated with cranberry extract at concentrations of 50 and 6.25 pg/ml or common chamomile extract at concentrations of 25 and 6.25 pg/ml, an increase in the percentage of stimulated NK cells expressing the CD25 receptor was observed, which may be equivalent to an increase in their cytotoxic activity (Table 7).

Table 7: Mean concentrations of IL-2 secreted by peripheral lymphocytes treated with American cranberry extract or common chamomile extract, or unstimulated cells

cRPMI American cranberries [pg/ml] Common chamomile [pg/ml] 50 6.25 3.125 25 6.25 3.125 IL-2 (pg/ml) 7.49±2.63 18.77+8.30 17.05+5.72 8.77±8.30 12.11+3.42 12.43+9.71 9.05±9.05 P p>0.05 p<0.05 p<0.05 p>0.05 p<0.05 p<0.05 p>0.05

p calculated in comparison to the unstimulated culture using the Mann Whitney U test for non-parametric tests

An increase in the percentage of NK cells and such cells with the CD25 receptor in response to cranberry extract at concentrations of 50 and 6.25 pg/ml and chamomile extract at concentrations of 25 and 6.25 pg/ml was associated with the secretory activity of such cells in terms of IL-2 secretion (increase in IL-2 secretion).

The examples presented above show that the base composition according to the invention, containing a mixture of extracts from common chamomile, common thyme, common marjoram and American cranberry in the proportion of thyme extract: common chamomile: common marjoram: American cranberry is: 100:12.5:6 .25:100, supports the activity of monocytes and natural killer (NK) cells by stimulating these cells to secrete appropriate cytokinins, which makes the composition according to the invention particularly useful in the treatment of infections /7. pylori. An important aspect of the activity of the plant extracts according to the invention is that the effect of the above plant extracts in terms of stimulating monocytes of the THP1XBIue™ line can be described as moderately strong, because it is half of the range induced by the control factor - E. coli LPS, making them suitable substances with immunoprotective potential because they do not cause excessive immunostimulation that may lead to an undesirable inflammatory reaction.

Therefore, the developed composition of plant extracts ensures that the activity of appropriate cells is increased to a moderately strong level, i.e. optimal for combating infections occurring in the body, such as infection /7. pylori, as well as the prevention of such infections, while preventing excessive activity of the immune system, which could cause its pro-inflammatory effect. For this reason, the developed composition ensures stimulation of immune system cells appropriate for both the treatment and prevention of infections /7. pylori - and therefore in its medical use.

It is to be understood that the foregoing description relates to embodiments of the invention which are illustrative and explanatory only and do not limit the invention in any way. Any changes or modifications may be made to the embodiments as will be apparent to those skilled in the art. Such variations are to be contemplated within the scope of the invention as defined in the following claims.

Claims (10)

1. A composition containing a mixture of extracts from: - thyme (Thymus vulgaris L) with a DER of 10:1 obtained by water extraction of the above-ground part of this plant; - common chamomile (Matricaria recutita) with a DER of 4:1 obtained by water-alcoholic extraction of the flowers of this plant, with a water-alcohol volume (v:v) of 1:1; - marjoram (Origanum vulgare) with a DER of 5:1 obtained by water-alcoholic extraction of the above-ground part of this plant, with a water-alcohol volume (v:v) of 1:1; and - American cranberries (Vaccinium) with a DER of 18:1 obtained by water extraction of the fruits of this plant; characterized in that the extracts in the mixture are in the proportions thyme extract: common chamomile extract: marjoram extract: American cranberry extract of 100: 12.5: 6.25: 100, to be used to support the body's immunity in prevention and treatment of Helicobacter pylori infections. 2. The composition for use according to claim 1, characterized in that the composition contains American cranberry extract at a concentration of 6.5 μg/ml to 50 μg/ml. 3. The composition for use according to one of claims 1 to 2, characterized in that the extracts are contained in the composition in liquid, semi-solid or solid form. 4. The composition for use according to one of claims 1 to 3, characterized in that it is in the form of tablets, capsules, sachets, suspension, gel or syrup. 5. The composition for use according to claim 4, characterized in that the composition additionally contains probiotics. 6. The composition for use according to claim 4 or 5, characterized in that the composition additionally contains beta-Iucan. 7. The composition for use according to one of claims 4 to 6, characterized in that the composition additionally contains cistus extract. 8. The composition for use according to one of claims 1 to 7, characterized in that it is taken in a dose containing 100 mg of thyme extract, 12.5 mg of common chamomile extract, 6.25 mg of marjoram extract and 100 mg of extract from American cranberries. 9. The composition for use according to claim 8, characterized in that the single dose is taken twice daily before meals. 10. The composition for use according to claim 8, characterized in that a double dose of the composition is taken once a day before a meal.