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

Primary Purpose

Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
kombucha-based beverage
Sponsored by
Vasily Isakov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation focused on measuring specialized food product, kombucha, safety, efficacy, constipation, functional food

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention/kombucha-based beverage

Control

Arm 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"

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

Outcomes

Primary Outcome Measures

Change of number bowel movements
Number of bowel movements per week will be assessed per patients self report
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)

Secondary Outcome Measures

Adverse events
Number of adverse events

Full Information

First Posted
December 4, 2021
Last Updated
September 1, 2023
Sponsor
Vasily Isakov
Collaborators
Azbuka vkusa, Russian Science Foundation, Federal Research Centre of Nutrition, Biotechnology and Food Safety
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1. Study Identification

Unique Protocol Identification Number
NCT05164861
Brief Title
Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha in Patients With Constipations
Acronym
Kombucha
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vasily Isakov
Collaborators
Azbuka vkusa, Russian Science Foundation, Federal Research Centre of Nutrition, Biotechnology and Food Safety

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome
Keywords
specialized food product, kombucha, safety, efficacy, constipation, functional food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention/kombucha-based beverage
Arm Type
Experimental
Arm 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"
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects of this group will receive standard diet with similar quantity of water as in experimental group
Intervention Type
Dietary Supplement
Intervention Name(s)
kombucha-based beverage
Other Intervention Name(s)
Kombucha enriched with inulin, vitamins and flavours
Intervention Description
kombucha-based beverage: drinking water, black tea, kombucha, inulin, vitamins (B1, B2, B6, niacin, folic acid). Nutritional value in 100 ml: carbohydrates - 2.57 g (including sucrose - 0.22 g, glucose - 1.32 g, fructose - 1.03 g), inulin - 1.15 g (46%*), vitamin B1 - 0.4 mg (29%*), B2 - 0.21 mg (13%*), B6 - 0.48 mg (24%*), niacin - 2.74 mg (15%*), folic acid - 24.0 mcg (12%*). Energy value/Caloric content - 54 kilojoules/13 kcal (* - % of the recommended daily allowance, according to the Technical regulations of the Customs Union #022/2011). Flavours, identical by nutrient's content and nutrients density: black currant berries & juniper berries, or strawberries & lime leaves, or passion fruit & mango. Portion's volume - 220 ml. Daily intake: 1 portion
Primary Outcome Measure Information:
Title
Change of number bowel movements
Description
Number of bowel movements per week will be assessed per patients self report
Time Frame
two weeks
Title
Change of stool type
Description
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)
Time Frame
a week
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number of adverse events
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vasily Isakov, Professor
Organizational Affiliation
Federal Research Center of Nutrition and Biotechnology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology and Hepatology, FRC Nutrition and Biotechnology
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Blinded to personal data individual participant data may be shared per reasonable request after study completion
IPD Sharing Time Frame
study data will available during 5 years after study completion
IPD Sharing Access Criteria
per reasonable request to principal investigator
IPD Sharing URL
https://grant.rscf.ru/
Links:
URL
https://theromefoundation.org/rome-iv/rome-iv-criteria/
Description
Rome IV criteria

Learn more about this trial

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

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