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

Assessment of Safety and Efficacy of Non-alcoholic Pasteurized Beverage Based on Kombucha, Enriched With Inulin and Vitamins in Patients With Constipations

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Constipation; Constipation-predominant Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: kombucha-based beverage

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115446
    • Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention/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"	Dietary supplement: kombucha-based beverage; 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; Other Names: Kombucha enriched with inulin, vitamins and flavours
No Intervention: Control; Subjects of this group will receive standard diet with similar quantity of water as in experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number of adverse events	two weeks

Collaborators and Investigators

• Sponsor: Vasily Isakov
• Collaborators: Russian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition, Biotechnology and Food Safety
• Investigators: Principal Investigator: Vasily Isakov, Professor, Federal Research Center of Nutrition and Biotechnology

Publications and helpful links

Helpful Links

• Rome IV criteria

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 18, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: safety; efficacy; constipation; functional food; kombucha; specialized food product
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 19-76-30014/2021K-OGIG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No