Irritable Bowel Syndrome With Constipation Clinical Trial
— KombuchaOfficial title:
Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
Verified date | September 2023 |
Source | Russian Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 40 |
Est. completion date | July 28, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Gastroenterology and Hepatology, FRC Nutrition and Biotechnology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Vasily Isakov | Azbuka vkusa, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Russian Science Foundation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of number bowel movements | Number of bowel movements per week will be assessed per patients self report | two weeks | |
Primary | 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 | |
Secondary | Adverse events | Number of adverse events | two weeks |
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