NL2038663B1

NL2038663B1 - Usage of probiotic composition of dragon fruit in rapidly promoting defecation and maintaining intestinal microbiota stability

Info

Publication number: NL2038663B1
Application number: NL2038663A
Authority: NL
Inventors: Stepanko Olga
Original assignee: Sunbird Company Ltd
Priority date: 2024-09-19
Filing date: 2024-09-19
Publication date: 2025-05-14

Abstract

Disclosed is the usage of a probiotic composition in rapidly promoting defecation and maintaining intestinal microbiota stability, and relates to the field of probiotic supplements. The present invention provides a composition of specific components and formulations, which, under the action of probiotics, water-soluble dietary fibre, and dragon fruit powder, rapidly promotes adult defecation within 24 hours and quickly addresses constipation problems in patients; the composition has high safety and contains no laxative ingredients that irritate the intestines; the three types of probiotics balance the gut microbiota to maintain long-term regular bowel movements for patients. Adding bamboo extract powder during the preparation process of powder can improve the flowability of powder and make the components more evenly mixed.

Description

USAGE OF PROBIOTIC COMPOSITION OF DRAGON FRUIT IN RAPIDLY PROMOTING

DEFECATION AND MAINTAINING INTESTINAL MICROBIOTA STABILITY

TECHNICAL FIELD

The present invention relates to the field of probiotic supplements, specifically to the usage of a probiotic composition in rapidly promoting defecation and maintaining intestinal microbiota stability.

BACKGROUND

Constipation is a common clinical symptom caused by various pathological factors, mainly manifested as infrequent bowel movements, difficulty in defecation, or hard stool. According to survey results, a considerable proportion of people have experienced constipation, and its harm to health is often overlooked because it rarely leads to hospitalization or death. However, its high incidence rate and complex aetiology often bring patients a lot of pain and trouble, seriously affecting people's health and quality of life. Modern medicine has confirmed that long-term constipation can induce various diseases, such as rectal cancer, hypertension, stroke, and so on.

Constipation, when appear, needs to be taken seriously and treated appropriately.

Numerous studies have demonstrated that probiotics and dietary fibre are increasingly favoured by researchers due to their safety and effectiveness in constipation improvement.

Probiotics, active microorganisms beneficial to the human body, can improve intestinal health through various mechanisms, especially in constipation relief. Probiotics can help restore and maintain the balance of intestinal flora, and improve the gut environment by inhibiting the growth of harmful bacteria and promoting the proliferation of beneficial bacteria; certain probiotics can stimulate intestinal peristalsis, promote the movement and excretion of faeces. In addition, probiotics can also increase water absarption in the intestine, promote the secretion of intestinal mucus, and make it easier to excrete; probiotics, on the other hand, can enhance the immune function of the intestine and reduce intestinal inflammation. Intestinal inflammation and immune dysfunction are also factors leading to constipation.

Bifidobacterium animalis subsp. Lactis, a probiotic belonging to the genus Bifidobacterium, are widely present in the intestines of humans and animals, and play an important role in maintaining intestinal health and enhancing the immune system. In terms of improving the digestive system, it can regulate gastrointestinal balance and effectively alleviate symptoms of chronic and acute diarrhoea, can also promote gastrointestinal peristalsis, help alleviate constipation symptoms, and improve difficulty in defecation. The experimental results in the literature (doi: 10.1080/19480976, 2017.1421908) demonstrated that the population diagnosed with functional constipation, after taking Bifidobacterium animalis subsp. lactis HN019 for 28 days, has significantly increased bowel frequency, improved functional constipation, and better facilitated regular bowel movements.

Dragon fruit powder, a powder made from ground dried dragon fruit, is rich in nutrients including dietary fibre, vitamins, minerals, and antioxidants. Dietary fibre can increase the volume and weight of faeces, promote intestinal peristalsis, and help relieve constipation. Soluble fibre can absorb water to form gel like substances, and make faeces soft to discharge easily;

Meanwhile, fibre can serve as a food source for gut probiotics to promote their growth and improve the gut microbiota environment, thereby alleviating the constipation. In addition, rich antioxidants such as vitamin C and anthocyanins can help reduce intestinal inflammation and promote intestinal health. Dragon fruit seed is a small black seed in dragon fruit, usually consumed together with dragon fruit. It is also rich in dietary fibre, and can promote intestinal peristalsis, help digestion, and prevent constipation. Dragon fruit seed liquid is rich in minerals such as magnesium, calcium, iron, and zinc, and these minerals play important roles in immune function and overall metabolism.

A large number of studies suggested that the changes in gut microbiota environment of constipation patients are mainly manifested as a significant reduction in the number of bifidobacteria beneficial to the human body, excessive growth of potential pathogenic bacteria and foreign pathogenic bacteria, and the occurrence of intestinal dysfunction symptoms such as constipation. At present, in the field of Western medicine, drugs such as laxatives and prokinetic agents are mostly used for treatment, but taking such drugs can only temporarily relieve patients’ symptoms, and will impose many side effects, stimulate the intestines and easily form drug dependence. So, it is very necessary to carry out R&D on probiotic treatment methods.

There is an urgent need for a composition to meet people's needs that can quickly promote defecation, improve intestinal motility, and balance the gut microbiota, while also having minimal side effects and causing no disruption to the gut microbiota.

SUMMARY

The present invention, on the one hand, provides a probiotic composition comprising probiotics, and the viable count of probiotics in each 1 g composition is 2.5 - 60 billion.

In some embodiments, the probiotic composition also comprises bamboo extract.

In some embodiments, the bamboo extract in each 1 g composition is 9 - 225 mg, preferably 12-75mg.

In some embodiments, the bamboo extract in each 1 g composition is 15 - 25 mg.

In some embodiments, the bamboo extract is prepared as follows: wash and slice fresh bamboo leaves for pretreatment, steam and filter the treated bamboo to obtain the filtrate, and then obtain bamboo extract through reduced pressure distillation.

In some embodiments, probiotics include but are not limited to Bifidobacterium lactis,

Lactobacillus rhamnosus, Bacillus coagulans, Lactobacillus plantarum, Lactobacillus acidophilus,

Bifidobacterium animalis, Bifidobacterium bifidum, Bifidobacterium infantis, Lactobacillus casei,

Bifidobacteria, Lactobacillus Raman, Bifidobacterium longum, Bifidobacterium brevis, and

Bifidobacterium thermophilus.

In some embodiments, probiotics include Bifidobacterium animalis subsp. lactis,

Lactobacillus rhamnosus, and Lactobacillus plantarum.

In some embodiments, the viable count of probiotics in each 1 g composition is 10 - 40 billion, preferably 17.5 - 20 billion.

In some embodiments, the composition further comprises water-soluble dietary fibre, including but not limited to polydextrose, fructooligosaccharides, isomaltooligosaccharide, oligolactose, xylo-oligosaccharide, soy oligosaccharides, agar powder, carboxymethyl cellulose, cereal dietary fibre, dietary fibre from vegetable and fruit, dietary fibre from nut and seed, and seaweed dietary fibre.

In some embodiments, cereal dietary fibre includes but is not limited to dietary fibre in whole grains, miscellaneous grains, legumes, and other foods, specifically including sweet potatoes, purple potatoes, corn, brown rice, barley, buckwheat, oats, kidney beans, mung beans, adzuki beans, broad beans, peas, cowpeas, lentils, and black beans.

In some embodiments, vegetable and fruit dietary fibre includes but is not limited to broccoli, carrots, apples, bananas, cucumbers, loofah, eggplants, tomatoes.

In some embodiments, dietary fibre from nuts and seeds includes but is not limited to almonds, flaxseeds, chia seeds, walnuts, pistachios, and pine nuts.

In some embodiments, seaweed dietary fibre includes but is not limited to pak choi, seaweed, and kelp.

In some embodiments, the ratio of viable count of probiotics to water-soluble dietary fibre mass is 2.5 - 60 billion: 36 - 810 mg, preferably 10 - 40 billion : 48 - 270 mg, and further preferably 17.5 - 20 billion : 60 - 90 mg.

In some embodiments, the mass of water-soluble dietary fibre in each 1g composition is 36 - 810 mg, preferably 48 - 270 mg, and further preferably 60 — 90 mg.

In some embodiments, the composition further comprises sugar alcohols, including but not limited to sorbitol, maltitol, mannitol, lactitol, erythritol, xylitol.

In some embodiments, the sugar alcohol is sorbitol.

In some embodiments, the ratio of viable count of probiotics to sugar alcohol mass is 2.5-60billion: 0.36 - 8.1 g, preferably 10 - 40 billion : 0.48 - 2.7 g, and further preferably 17.5 - 20 billion: 0.6 - 0.9 g.

In some embodiments, the mass of sugar alcohol in each 1 g composition is 0.36 - 8.1 g, preferably 0.48 - 2.7 g, and further preferably 0.6 - 0.9 g.

In some embodiments, the composition also comprises dragon fruit powder, and the ratio of viable count of probiotics to the mass of dragon fruit powder is 10 - 240 billion : 0.5 - 10 mg, preferably 40 - 160 billion : 0.5 - 10 mg, and further preferably 70-80 billion : 0.5 - 10 mg.

In some embodiments, the mass of dragon fruit powder in each 1g composition is 0.1 - 2.5 mg, specifically 0.1, 0.2,0.3,0.4,0.5,06,0.7,08,09,1,1.1,1.2,1.3, 1.4, 1.5, 16, 1.7, 1.8, 1.9,

20,21,22,23,2.4,and 2.5.

In some embodiments, the composition also comprises yogurt powder.

The present invention, on the other hand, provides a product that is prepared from the above- mentioned composition into tablets, capsules, powders, oral liquids, suspensions, jellies, gummies, or crystal balls.

In some embodiments, a powder is prepared from the composition described above.

In some embodiments, the powder is prepared as follows: mix the powder of various substances in the composition evenly, and then fill them to obtain the product.

The present invention, on the other hand, provides a use of the above-mentioned composition and product that can rapidly promote defecation, maintain intestinal microbiota balance, and improve intestinal motility.

In some embodiments, the composition provided by the present invention is administered 1-2 bags per day, taken directly, or taken with water below 37°C.

The present invention has the following beneficial effects: 1. The composition, under the action of probiotics, water-soluble dietary fibre, and dragon fruit powder, rapidly promotes adult defecation within 24 hours and quickly addresses constipation problems in patients; 2. The composition has high safety, and contains no laxative ingredients that irritate the intestines; 3. The three types of probiotics balance the gut microbiota to maintain long-term regular bowel movements for patients. 4. Adding bamboo extract powder during the preparation process of powder can improve the flowability of powder and make the components more evenly mixed.

DETAILED DESCRIPTION OF EMBODIMENTS

In order to facilitate the understanding of those skilled in the art, the present invention will be further elaborated in conjunction with the embodiments below, and the content mentioned in the embodiments is not a limitation of the present invention.

Example 1

A composition, 4 g, wherein the probiotic powder contains Bifidobacterium animalis subsp. lactis HNO 19, Lactobacillus rhamnosus GG, and Lactobacillus plantarum PL15A, with a total of 75 billion viable probiotics; 300 mg polydextrose; 3,000 mg sorbitol, appropriate amount of dragon fruit powder and 80 mg bamboo extract powder.

Example 2

A composition, 4 g, wherein the probiotic powder contains Bifidobacterium animalis subsp. factis HNO19, Lactobacillus rhamnosus GG, and Lactobacillus plantarum PL15A, with a total of

70 billion viable probiotics; 240 mg polydextrose; 3,600 mg sorbitol, appropriate amount of dragon fruit powder and 60 mg bamboo extract powder.

Example 3 5 A composition, 4 g, wherein the probiotic powder contains Bifidobacterium animalis subsp. lactis HNO19, Lactobacillus rhamnosus GG, and Lactobacillus plantarum PL15A, with a total of 80 billion viable probiotics; 360 mg polydextrose; 2,400 mg sorbitol; appropriate amount of dragon fruit powder and 100 mg bamboo extract powder.

Comparison Example 1

A composition, 4 g, wherein probiotic powder contains Bifidobacterium bifidum B11,

Lactobacillus rhamnosus GG, and Lactobacillus plantarum PL15A, with a total of 75 billion viable probiotics; 300 mg polydextrose; 3,000 mg sorbitol, appropriate amount of dragon fruit powder and 80 mg bamboo extract powder.

Comparison Example 2

A composition, 4 g, wherein probiotic powder contains Bifidobacterium animalis subsp. lactis

HNO19, Lactobacillus rhamnosus GG, and Lactobacillus casei LC-12, with a total of 75 billion viable probiotics; 300 mg polydextrose; 3,000 mg sorbitol; appropriate amount of dragon fruit powder and 80 mg bamboo extract powder.

Comparison Example 3

HNO19, Lactobacillus casei LC-12, Lactobacillus plantarum PL15A, with a total of 75 billion viable probiotics; 300 mg polydextrose; 3,000 mg sorbitol; 80 mg bamboo extract powder.

Comparison Example 4

A composition, 4 g, wherein probiotic powder contains Bifidobacterium animalis subsp. lactis,

Lactobacillus rhamnosus, and Lactobacillus plantarum, with a total of 75 billion viable probiotics; 300mg polydextrose; 3,000 mg lactitol; appropriate amount of dragon fruit powder and 80 mg bamboo extract powder.

Comparison Example 5

Lactobacillus rhamnosus, and Lactobacillus plantarum, with a total of 75 billion viable probiotics; 300mg fructooligosaccharides; 3,000 mg sorbitol; appropriate amount of dragon fruit powder and 80 mg bamboo extract powder.

Comparison Example 6

HNO19, Lactobacillus rhamnosus GG, and Lactobacillus plantarum PL15A, with a total of 75 billion viable probiotics; 300 mg polydextrose; 3,000 mg sorbitol; appropriate amount of dragon fruit powder.

Example 6 Experiment on the evaluation of faecal promotion function 55 mice were randomly divided into blank control group, model control group, example groups 1 - 8, and positive control group, with 5 mice in each group. Except for the blank control group, all other groups of mice were deprived of water but given with food for 72 hours, resulting in a dry and dehydrated constipation model.

Medicine was administered as follows: blank control group: free diet; Model control group: given with food but no water; Positive control group: given with food but no water, fed with compound diphenoxylate at a dosage of 15mg/(kg-d); Example groups 1 - 8: Prepare a suspension with concentration of 2g/L from the composition of Example 1 - 8 of the present invention and the distilled water at a dosage of 250mg/(kg-d), and administer it by gavage.

After administration, the mice were placed in a mouse cage, which bottom is covered with clean white filter paper, the first defecation time (min) of each mouse and the total weight of mouse faeces within 24 hours were observed and recorded, with the results shown in Table 1.

First defecation time: the time elapsed from the end of gastric lavage to the first defecation.

Table 1

Group First black stool time we 2 0

Example 7: Effect of composition on improving constipation

Trial purpose: Verify the effect of Example 1 in improving constipation

Population inclusion: The inclusion criteria for subjects were as follows (as long as one of the criteria was met): (D Frequency of defecation: <2 times/week; (2) People with difficulty in defecation; (3) Hard faeces; (£) Individuals who believe they need to improve their bowel movements or constipation.

Experimental design: A total of 17 subjects, taking Example 1 for 3 consecutive days;

Usage: Those who meet 1 or 2 inclusion criteria take 1 bag on the first day, and 2 bags depending on the effect on the first day;

Those who meet 3 inclusion criteria take 2 bags directly on the first day;

Those who only meet inclusion criteria (4) take 1 bag on the first day, and 2 bags according to the effect on the first day;

Content of questionnaire: 1. Main criteria: (1) frequency of defecation; (2) Defecation condition; (3) Faecal condition; (2)

Faecal volume; 5) Defecation time; 2. Secondary criteria: Record the presence of adverse reactions (nausea, vomiting, diarrhoea, abdominal pain, abnormal stool, etc.).

Table 2

After taking / Regardless of

Indicator Subgroup / / / Before taking One bag per dosage, 1-2 analysis/explanation day bags are included

Everyone (17 people 10.18 10.44 7.79 times/week in total) times/week times/week

Subjects with bowel

Average frequency | movements < once a 9.67 10.12 4.8 times/week of bowel movements day (a total of 13 times/week times/week per week subjects)

Subjects with bowel movement frequency 9.92 9.92 2.92 times/week

S once every 2 days times/week times/week (a total of 7 subjects}

Everyone (17 70.59% 70.59%

Percentage of subjects in total) subjects with Subjects with bowel / increased frequency | movements S once a 84.62% 92.31% of bowel movements day (a total of 13 people)

Subjects with bowel movement frequency < once every 2 days 100.00% 100.00% (a total of 7 subjects) subjects / experiencing bowel 24h 93.9% 93.9%

Proportion of subjects who experience at least 94.10% 100% one smoother bowel

Is defecation movement smoother Proportion of subjects with at least half of their bowel 76.5% 71% movements being smoother

Proportion of Increased frequency subjects with overall and shortened improvement in duration of bowel / 100% 100% bowel movements movements

Example 8 Determination of powder fluidity

Determine the angle of repose of the composition prepared in Examples 1-3 and Comparison

Example 6 using the injection method. Example 1 shows the best fluidity, Examples 2-3 show insignificant differences, with the angle of repose between 30-40°, and Comparison Example 6, however, shows poor fluidity, with the angle of repose greater than 50°.

Table 3

It should be understood that the detailed description of the technical solution of the present invention with the help of preferred embodiments is illustrative rather than restrictive. The persons with ordinary skill in the art may modify the technical solutions described in each embodiment based on reading the present invention specification, or equivalently replace some of the technical features, and these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the embodiments of the present invention.

Claims

CONCLUSIONS

1. A probiotic composition of dragon fruit powder, comprising probiotics, polydextrose and sorbitol, wherein the ratio of the mass of polydextrose, the mass of sorbitol and the number of viable probiotic cells in the composition is 60 -90 mg : 0.8 -0.9g : 17.5- 20 billion.

2. The composition of claim 1, further comprising bamboo extract, wherein the mass of the bamboo extract in the composition is 15 - 25 mg/g.

3. The composition according to claim 2, wherein the composition is prepared as follows: washing and cutting fresh bamboo leaves for pretreatment, steaming and filtering the treated bamboo to obtain a filtrate, and then obtaining bamboo extract by distillation under reduced pressure.

4. The composition according to claim 1, wherein the probiotics are Bifidobacterium animalis subsp. /actis, Lactobacillus rhamnosus and Lactobacillus plantarum.

5. The composition according to claim 1, wherein the number of viable probiotics in the composition is 17.5 - 20 billion/g.

6. The composition according to claim 1, further comprising dragon fruit powder.

7. The composition according to claim 6, wherein the ratio of the number of viable probiotics to the mass of the dragon fruit powder is 70 - 80 billion : 0.5 - 10 mg.

8. The composition of claim 1, further comprising yoghurt powder.

9. A product prepared as a powder from the composition according to any one of claims 1 to 8.

10. Use of the composition according to any of claims 1 to 8 or the product according to claim 9 for rapid promotion of bowel movements, for maintaining the balance of the intestinal microbiota and for improving intestinal motility.