Clinical trial NCT05164861: Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
Official title: Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Constipation
Constipation-predominant Irritable Bowel Syndrome
Keywords: specialized food product
kombucha
safety
efficacy
constipation
functional food
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Azbuka vkusa
name: Russian Science Foundation
name: Federal Research Centre of Nutrition, Biotechnology and Food Safety
First posted: 2021-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of number bowel movements
timeFrame: two weeks
measure: Change of stool type
timeFrame: a week
Secondary outcomes:
measure: Adverse events
timeFrame: two weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
Study officials:
affiliation: Federal Research Center of Nutrition and Biotechnology
name: Vasily Isakov, Professor
role: PRINCIPAL_INVESTIGATOR
References: