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Completed

NCT Number: NCT05164861

Safety and Efficacy of Non-alcoholic Beverage Based on Kombucha 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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastroenterology and Hepatology, FRC Nutrition and Biotechnology

Moscow, 115446, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Kombucha enriched with inulin, vitamins and flavours

Primary outcomes

  1. Change of number bowel movements

    Time frame: two weeks

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

  2. Change of stool type

    Time frame: a week

    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 outcomes

  1. Adverse events

    Time frame: two weeks

    Number of adverse events

Sponsors and collaborators

Lead sponsor

Vasily Isakov

Other

Collaborators

  • Azbuka vkusa
  • Federal State Budgetary Scientific Institution
  • Russian Science Foundation

Registry information

Official study title

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

Acronym: Kombucha

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2021
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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