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

Irritable Bowel Syndrome With Constipation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05164861
• Other study ID #: 19-76-30014/2021K-OGIG
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 28, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Constipation-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Constipation
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Gastroenterology and Hepatology, FRC Nutrition and Biotechnology	Moscow

Sponsors (4)

Lead Sponsor	Collaborator
Vasily Isakov	Azbuka vkusa, Federal Research Centre of Nutrition, Biotechnology and Food Safety, Russian Science Foundation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of number bowel movements	Number of bowel movements per week will be assessed per patients self report	two weeks
Primary	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	Adverse events	Number of adverse events	two weeks

External Links

•   Rome IV criteria