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

NCT05164861 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-06

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Azbuka vkusa

    collaborator UNKNOWN

  • Russian Science Foundation

    collaborator OTHER

  • Federal Research Centre of Nutrition, Biotechnology and Food Safety

    collaborator UNKNOWN

  • Vasily Isakov

    lead OTHER

Principal Investigators

  • Vasily Isakov, Professor · Federal Research Center of Nutrition and Biotechnology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-01-31
Completion
2023-07-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164861 on ClinicalTrials.gov