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

NCT05164861 | Completed DMC

• 1 other identifier: 19-76-30014/2021K-OGIG
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

specialized food product; kombucha; safety; efficacy; constipation; functional food

Outcome Measures

Primary Outcomes (2)

• Change of number bowel movements

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

  two weeks

• 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)

  a week

Secondary Outcomes (1)

• Adverse events

  two weeks

Study Arms (2)

Intervention/kombucha-based beverage

EXPERIMENTAL

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"

Dietary Supplement: kombucha-based beverage

Control

NO INTERVENTION

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

Interventions

kombucha-based beverage DIETARY_SUPPLEMENT

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

Also known as: Kombucha enriched with inulin, vitamins and flavours

Intervention/kombucha-based beverage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vasily Isakov: lead
• Azbuka vkusa: collaborator
• Russian Science Foundation: collaborator
• Federal Research Centre of Nutrition, Biotechnology and Food Safety: collaborator

Study Sites (1)

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, 115446, Russia

Location

Related Publications (2)

• Isakov VA, Pilipenko VI, Vlasova AV, Kochetkova AA. Evaluation of the Efficacy of Kombucha-Based Drink Enriched with Inulin and Vitamins for the Management of Constipation-Predominant Irritable Bowel Syndrome in Females: A Randomized Pilot Study. Curr Dev Nutr. 2023 Nov 24;7(12):102037. doi: 10.1016/j.cdnut.2023.102037. eCollection 2023 Dec.

  PMID: 38149073 DERIVED

• Pilipenko VI, Isakov VA, Morozov SV, Vlasova AV, Kochetkova AA. [Efficacy of newly developed kombucha-based specialized food product for treatment of constipation-predominant irritable bowel syndrome]. Vopr Pitan. 2022;91(5):95-104. doi: 10.33029/0042-8833-2022-91-5-95-104. Epub 2022 Aug 30. Russian.

  PMID: 36394933 DERIVED

Related Links

• Rome IV criteria

MeSH Terms

Conditions

Constipation

Interventions

Inulin; Vitamins

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vasily Isakov, Professor

  Federal Research Center of Nutrition and Biotechnology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD, AGAF

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 21, 2021
• Study Start: November 1, 2021
• Primary Completion: January 31, 2023
• Study Completion: July 28, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: study data will available during 5 years after study completion
• Access Criteria: per reasonable request to principal investigator

Locations

RU (1)