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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Moscow, Russia
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
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