Dietary supplement for the treatment of constipation

Abstract

The present invention describes a dietary supplement consisting of a first plurality of daily doses of a laxative composition (A) comprising Psyllium, MgO, and fennel dry extract.; and a second plurality of daily doses of a probiotic and prebiotic composition (B) comprising B. lactis, B. longum, and FOS. Subject-matter of the present invention is therefore also a food supplement as described above for use in the treatment of constipation, linked to the intake of drugs, constipation-predominant IBS, chronic constipation, or acute constipation, characterized in that the plurality of doses of composition (B) are taken sequentially to a number of doses of composition (A).

Description

[0001] INDUSTRIAL INVENTION PATENT APPLICATION TITLED:

[0002] DIETARY SUPPLEMENT FOR THE TREATMENT OF CONSTIPATION

[0003] FIELD OF THE INVENTION

[0004] The present invention refers to the field of dietary supplements for the treatment of constipation.

[0005] STATE OF THE ART

[0006] Constipation (also known as bowel irregularity or costiveness) is one of the most common gastrointestinal disorders and is defined as a defecation disorder consisting of difficulty emptying the bowel and expelling stool; a frequency is generally considered physiological if it occurs between 3 times a day and 3 times a week. When food passes through the colon, which is a section of the large intestine, it absorbs any remaining water and forms waste products, namely stool, which muscular contractions push toward the rectum. By the time the stool reaches the rectum, it is solid because most of the water has been absorbed. Constipation occurs when the colon absorbs too much water, or when colon muscular contractions are too slow and weak, causing a slow movement that makes the stool hard and dry (and therefore more difficult to evacuate).

[0007] There are various types of constipation, such as acute constipation, chronic constipation, constipation as an IBS related condition, drug-induced constipation, etc..

[0008] A number of possible remedies for treating constipation are known.

[0009] Psyllium is a fiber obtained from the herbaceous plant Plantago Psyllium, specifically from its seeds and the outer covering of the seeds, called the cuticle. Its beneficial properties are recognized primarily for restoring proper intestinal transit and digestive system functions. It is a white, fibrous, and, above all, hydrophilic material, which means it can increase in volume (up to 10 times) by absorbing and retaining water. Its structure allows the mucilage to attract fluids into the intestine, making stool much softer and facilitating evacuation, thus performing an emollient and soothing action and having a prebiotic effect. Magnesium oxide (MgO) is highly hygroscopic; in the presence of water, it is transformed into a hydrated form known as magnesium hydroxide (Mg(OH)2), which is primarily known for its use as a laxative.

[0010] Fennel dry extract promotes regular gastrointestinal motility and gas elimination.

[0011] Probiotic bacteria of the B. lactis species are the most commonly present in fermented dairy products. B. lactis has an anti-inflammatory effect because it produces short-chain fatty acids (SCFAs), including butyrate and propionate, which are used as an energy source by colon cells. The production of SCFAs, combined with the acidification caused by B. lactis growth, results in the creation of an unfavorable environment for the growth of Enterobacteriaceae, Gram -negative bacteria commonly responsible for infectious colitis. B. lactis may help reduce intestinal transit time, relieve symptoms of irritable bowel syndrome (IBS), improve immune response, and protect against gastrointestinal infections.

[0012] Probiotic bacteria of the Bifidobacterium longum species are known for their role in promoting intestinal health. These probiotic bacteria can help maintain the balance of intestinal flora, improving digestive function and reducing the symptoms of gastrointestinal disorders such as constipation, diarrhea, bloating, and irritable bowel syndrome (IBS). Some studies suggest that this probiotic strain may have positive effects on the immune system, helping strengthen the body’s defenses against infections and improving the immune response.

[0013] FOS, short for fructooligosaccharides, are soluble fibers found in various common fruits, vegetables, and plants. Chemically, fructooligosaccharides consist of 3-5 monosaccharide units (D-glucose and D-fructose). FOS are very important in the nutritional and health fields, where they are used as “artificial” sweeteners and especially as prebiotics. FOS reach virtually unchanged the cecum and colon, where they selectively stimulate the growth and metabolic activity of beneficial strains, such as Bifidobacteria infantis, adolescentis, and longum. These probiotic bacteria use the sugars in FOS to grow and reproduce, producing short-chain organic acids (acetic, lactic, and formic) that inhibit the pathogens growth. The above activity explains the functional and metabolic role of FOS.

[0014] These remedies are well-known and commercially available, both individually and in combination. Constipation is a problem with high individual variability as well as dependent on multiple factors, and therefore the need for increasingly new remedies that are more effective, or at least alternative to those already on the market, is apparent.

[0015] SUMMARY OF THE INVENTION

[0016] Subject-matter of the present invention is a dietary supplement consisting of a kit for sequential and / or separate use, said kit consisting of: a first plurality of daily doses of a laxative composition (A) comprising Psyllium, MgO, and fennel dry extract; and a second plurality of daily doses of a probiotic and prebiotic composition (B) comprising B. lactis, B. longum, and FOS.

[0017] The dietary supplement of the invention has proven particularly effective in treating various types of constipation, promoting evacuation following the intake of 1 -4 doses, and on average 2-3 doses, of composition (A), and maintaining regularity with subsequent intake of doses of composition (B).

[0018] Subject-matter of the present invention is therefore also a dietary supplement as described above for use in the treatment of constipation and characterized in that a dose of composition (A) is taken daily for a predetermined number of consecutive days, and then sequentially and separately a dose of composition (B) is taken for a predetermined number of subsequent consecutive days.

[0019] DETAILED DESCRIPTION OF THE INVENTION

[0020] Preferably, the doses of compositions A and B are packaged in sachets.

[0021] The content of the sachets is to be dissolved in water or other liquid, preferably approximately 150 mL, for oral administration.

[0022] Preferably, the first plurality of doses of composition A consists of 6 sachets, each containing a daily dose of composition A. Generally, 1 -4 doses of composition A are sufficient to induce evacuation.

[0023] Preferably, the second plurality of doses of composition B consists of 14 sachets, each containing a daily dose of composition B.

[0024] According to a preferred embodiment of the present invention, for the treatment of constipation, the intake of one dose of composition A per day for 2-3 days is recommended. Thereafter, the intake of one dose of composition B per day for 7 days is recommended. For the following 10 days, it is recommended to repeat the same dosage regimen. Both sachets A and B should preferably be dissolved in 150 mL of water.

[0025] According to another preferred embodiment of the present invention, for the treatment of constipation, the intake of one dose of composition A per day until evacuation occurs is recommended. Subsequently, the intake of one dose of composition B per day until the doses in the kit are complete, is recommended. It may be necessary to sporadically take another 1 -2 doses of composition A during the days in which the doses of composition B are taken, suspending the intake of composition B and then resuming it.

[0026] Psyllium is preferably from Plantago ovata Forssk, Plantago afra L., or Plantago indica L..

[0027] Psyllium is preferably present in one dose of composition A in an amount of 2-8 g, more preferably 3-5 g, and even more preferably 4 g.

[0028] MgO is preferably present in one dose of composition A in an amount of 100-250 mg, more preferably 120-130 mg, and even more preferably 124.5 mg, corresponding to 75 mg of Mg; equal to approximately 20% of the NRV for magnesium.

[0029] Preferably, in one dose of composition A, the fennel dry extract is Foeniculum vulgare Mill, fruit dry extract, and it is present in an amount of 50-250 mg, more preferably 90-110 mg, and even more preferably 100 mg.

[0030] Preferably, one dose of composition A consists of:

[0031] Psyllium, preferably from Plantago ovata Forssk, 4 g

[0032] Magnesium oxide, 124.5 mg

[0033] Fennel dry extract, preferably Foeniculum vulgare Mill, fruit dry extract, 100 mg

[0034] Excipients

[0035] Flavoring agent, preferably orange flavor

[0036] Excipients of composition A are preferably citric acid (E330), silicon dioxide (E551 ), sucrose esters of fatty acids (E473), and sucralose (E955).

[0037] Preferably, in composition B, B. lactis is microencapsulated and present in an amount of 1 -3 billion, more preferably 1.5-2.5 or 1.8-2.2 billion, and even more preferably 2 billion. Preferably, in composition B, B. lactis is selected from the group consisting of BLA281 and BS01.

[0038] Preferably, in composition B, B. longum BL268 is microencapsulated and present in an amount of 0.5-2 billion, more preferably 0.5-1 .5 or 0.8-1 .2 billion, and even more preferably 1 billion. Preferably, in composition B, B. longum is selected from the group consisting of BL268 and BL03.

[0039] Preferably, in composition B, FOS are present in an amount of 1 -5 g, more preferably 2-3 g, and even more preferably 2.5 g.

[0040] Preferably, one dose of composition B consists of:

[0041] Microencapsulated B. lactis, preferably BLA281 , 2 billion;

[0042] Microencapsulated B. longum, preferably BL268, 1 billion;

[0043] FOS 2.5 g

[0044] Excipients

[0045] Unflavored

[0046] The excipients of composition B are preferably isomalt (E953) and silicon dioxide (E551 ).

[0047] The kit subject-matter of the present invention has proven useful in the treatment of various types of constipation, including drug-related constipation, constipation- predominant IBS, chronic constipation, and acute constipation.

[0048] The present invention may be better understood in light of the following examples.

[0049] EXPERIMENTAL PART

[0050] EXAMPLE 1 - Preparation of the laxative composition (A)

[0051] One dose of composition (A) according to the present invention consists of:

[0052] Psyllium from Plantago ovata Forssk, 4 g

[0053] Magnesium oxide, 124.5 mg

[0054] Fennel (Foeniculum vulgare Mill.) fruit dry extract, 100 mg

[0055] Excipients: citric acid (E330), silicon dioxide (E551 ), sucrose esters of fatty acids (E473), and sucralose (E955) as required

[0056] Orange flavor

[0057] EXAMPLE 2 - Preparation of the probiotic and prebiotic composition (B)

[0058] One dose of composition (B) according to the present invention consists of: Microencapsulated B. lactis BLA281 , 2 billion

[0059] Microencapsulated B. longum BL268, 1 billion

[0060] FOS, 2.5 g

[0061] Excipients: isomalt (E953) and silicon dioxide (E551 ) as required EXAMPLE 3

[0062] A sample of 47 patients aged 19 to 87 years and affected by acute constipation, chronic constipation, drug-related constipation, or constipation-predominant IBS, who underwent an observational study, showed statistically significant evacuation after taking 2-3 doses of composition A according to the present invention.

Claims

CLAIMS1 . A dietary supplement consisting of a kit for separate and sequential use, said kit consisting of: a first plurality of daily doses of a laxative composition (A) comprising Psyllium, MgO, and fennel dry extract; and a second plurality of daily doses of a probiotic and prebiotic composition (B) comprising B. lactis, B. longum, and FOS.

2. The dietary supplement according to claim 1 , wherein B. lactis is selected from the group consisting of BLA281 and BS01 , and B. longum is selected from the group consisting of BL268 and BL03.

3. The dietary supplement according to any one of claims 1-2, wherein Psyllium is from Plantago ovata Forssk., Plantago afra L., or Plantago indica L..

4. The dietary supplement according to any one of claims 1-3, wherein fennel dry extract is Foeniculum vulgare Mill, fruit dry extract.

5. The dietary supplement according to any one of claims 1-4, wherein the doses of compositions A and B are packaged in sachets.

6. The dietary supplement according to claim 5, wherein the first plurality of doses of composition A consists of 6 sachets each containing a daily dose of composition A, and the second plurality of doses of composition B consists of 14 sachets each containing a daily dose of composition B.

7. The dietary supplement according to any one of claims 1-6, wherein composition A comprises:Psyllium in an amount of 2-8 g, preferably 3-5 g;MgO in an amount of 100-250 mg, preferably 120-130 mg; and fennel dry extract in an amount of 100-250 mg, preferably 90-110 mg. Flavoring agent as required, preferably orange flavor.

8. The dietary supplement according to any one of claims 1-7, wherein composition B comprises:Microencapsulated B. lactis in an amount of 1-3 billion, preferably 1.5-2.5 or 1.8-2.2 billion;Microencapsulated B. longum in an amount of 0.5-2 billion, preferably 0.5-1 .5 or 0.8-1 .2 billion; andFOS in an amount of 1 -5 g, preferably 1 -3 g.

9. A dietary supplement according to any one of claims 1 -8 for use in the treatment of constipation, characterized in that a dose of composition (A) is taken daily for a predetermined number of consecutive days, and then sequentially and separately a dose of composition (B) is taken daily for a subsequent predetermined number of consecutive days.

10. The dietary supplement for use according to claim 9, wherein a dose of laxative composition (A) is taken daily for 2-3 consecutive days, subsequently a dose of probiotic and prebiotic composition (B) is taken daily for the following 7 days, and the aforementioned dosing regimen is repeated in the subsequent days.11 . The dietary supplement for use according to claim 9, wherein a dose of laxative composition (A) is taken daily for a number of consecutive days until evacuation is achieved, subsequently a dose of probiotic and prebiotic composition (B) is taken daily in the subsequent days until the second plurality of doses of composition (B) is exhausted.

12. The dietary supplement for use according to claim 11 , wherein during the days of administration of doses of composition B, if necessary, an additional 1 -2 doses of composition A are sporadically taken separately from the administration of composition (B).

13. The dietary supplement for use according to any one of claims 9-12, wherein constipation is drug-induced constipation, constipation-predominant IBS, chronic constipation, or acute constipation.