Constipation-predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome With Constipation
Conditions
Keywords
specialized food product, kombucha, safety, efficacy, constipation, functional food
Brief summary
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
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTkombucha-based beverage
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
Sponsors
Azbuka vkusa
Russian Science Foundation
Federal Research Centre of Nutrition, Biotechnology and Food Safety
Vasily Isakov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* willingness to participate (based on signed informed consent form) * irritable bowel syndrome with predominant constipation, per Rome IV criteria (Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: related to defecation; associated with a change in frequency of stool; associated with a change in form (appearance) of stool - Bristol stool scale types 1 or 2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis),
Exclusion criteria
* pregnant or breast-feeding women; * intolerance of kombucha or any component of the product; * history of abdominal surgery; * the use of concomitant medications able to affect bowel motility; * general condition of a patient making the appropriateness of his participation in the study questionable; * chronic decompensated disorders of any organs and systems; * mean daily caloric intake less than 800 kcal and more than 6000 kcal * inability to follow standard iso-caloric diet and standard volume of water consumption (1.5-2 litres a day)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of number bowel movements | two weeks | Number of bowel movements per week will be assessed per patients self report |
| Change of stool type | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | two weeks | Number of adverse events |
Countries
Russia
Outcome results
None listed