An interventional study of kombucha-based beverage in Irritable Bowel Syndrome With Constipation and Constipation-predominant Irritable Bowel Syndrome, sponsored by Vasily Isakov. Completed at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Vasily Isakov · Not applicable, Interventional, and Treatment
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.
1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 40 is below the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →This is the only study on the registry with Vasily Isakov as lead sponsor.
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Exclusion Criteria:
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"
Dietary Supplement: kombucha-based beverage
Subjects of this group will receive standard diet with similar quantity of water as in experimental group
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
Also known as: Kombucha enriched with inulin, vitamins and flavours
Change of number bowel movements
Number of bowel movements per week will be assessed per patients self report
Time frame: 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)
Time frame: a week
Adverse events
Number of adverse events
Time frame: two weeks
Plan to share: Yes — Blinded to personal data individual participant data may be shared per reasonable request after study completion
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: study data will available during 5 years after study completion
Access criteria: per reasonable request to principal investigator
Data sharing details ↗ · grant.rscf.ru
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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