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| Name | Class |
|---|---|
| Azbuka vkusa | UNKNOWN |
| Russian Science Foundation | OTHER |
| Federal State Budgetary Scientific Institution | OTHER_GOV |
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Single centre, open-label, non-randomized study is planned to proof the concept of safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with constipations
This single-center open-label non-randomized study is planned to proof the concept on safety and efficacy of newly developed specialized food product - non-alcoholic pasteurized beverage based on kombucha, enriched with inulin and vitamins in patients with irritable bowel syndrome with constipations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention/kombucha-based beverage | Experimental | Subjects randomized to this group will receive newly developed food product - non-alcoholic pasteurized beverage based on kombucha enriched with inulin and vitamins, flavoured as "Black currant with juniper" or "Strawberries with lime" or 'Mango with passion fruit" |
|
| Control | No Intervention | Subjects of this group will receive standard diet with similar quantity of water as in experimental group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kombucha-based beverage | Dietary Supplement | kombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%*), vitamin B1 - 0.4 mg (29%*), B2 - 0.21 mg (13%*), B6 - 0.48 mg (24%*), niacin - 2.74 mg (15%*), folic acid - 24.0 mcg (12%*). Energy value/Caloric content - 54 kilojoules/13 kcal (* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries & juniper berries, or strawberries & lime leaves, or passion fruit & mango. Portion's volume - 220 ml. Daily intake: 1 portion |
| Measure | Description | Time Frame |
|---|---|---|
| Change of number bowel movements | Number of bowel movements per week will be assessed per patients self report | two weeks |
| Change of stool type | Stool type assessed per the Bristol stool scale (from type 1 to type 7; where type 1 - separate hard lumps, like nuts, type 7 - watery, no solid pieces, entirely liquid stool - diarrhoea) | a week |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events | two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vasily Isakov, Professor | Federal Research Center of Nutrition and Biotechnology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and Hepatology, FRC Nutrition and Biotechnology | Moscow | 115446 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38149073 | Derived | Isakov VA, Pilipenko VI, Vlasova AV, Kochetkova AA. Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study. Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec. | |
| 36394933 |
| Label | URL |
|---|---|
| Rome IV criteria | View source |
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Blinded to personal data individual participant data may be shared per reasonable request after study completion
study data will available during 5 years after study completion
per reasonable request to principal investigator
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| D014815 | Vitamins |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Pilipenko VI, Isakov VA, Morozov SV, Vlasova AV, Kochetkova AA. [Efficacy of newly developed kombucha-based specialized food product for treatment of constipation-predominant irritable bowel syndrome]. Vopr Pitan. 2022;91(5):95-104. doi: 10.33029/0042-8833-2022-91-5-95-104. Epub 2022 Aug 30. Russian. |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |