Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations (NCT05164861) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
Russia40 participantsStarted 2021-11-01
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)