Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations

Not Applicable

Completed

• Conditions: Constipation-predominant Irritable Bowel Syndrome; Irritable Bowel Syndrome With Constipation
• Interventions: Dietary Supplement: kombucha-based beverage

• Registration Number: NCT05164861
• Lead Sponsor: Vasily Isakov

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.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-18
• Study First Posted: 2021-12-21
• Primary Completion: 2023-01-31
• Study Completion: 2023-07-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention/kombucha-based beverage	kombucha-based beverage	Subjects randomized to this group will receive newly developed food product - non-alcoholic pasteurized beverage based on kombucha enriched with inulin and vitamins, flavoured as "Black currant with juniper" or "Strawberries with lime" or 'Mango with passion fruit"

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse events	two weeks	Number of adverse events

Trial Locations

Locations (1)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology; 🇷🇺 Moscow, Russian Federation