Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, 115446, Russia
NCT Number: NCT05164861
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
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Moscow, 115446, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Kombucha enriched with inulin, vitamins and flavours
Time frame: two weeks
Number of bowel movements per week will be assessed per patients self report
Time frame: a week
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: two weeks
Number of adverse events
Vasily Isakov
Other
Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
Acronym: Kombucha
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