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

Vasily Isakov

Status: Completed

Conditions: Irritable Bowel Syndrome With Constipation; Constipation-predominant Irritable Bowel Syndrome

Treatments: Dietary Supplement: kombucha-based beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT05164861

19-76-30014/2021K-OGIG

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention/kombucha-based beverage

Experimental group

Description:

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"

Treatment:

Dietary Supplement: kombucha-based beverage

Control

No Intervention group

Description:

Subjects of this group will receive standard diet with similar quantity of water as in experimental group