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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-07-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults

NCT05447481

Constipation - Functional

COMPLETED NA

Kiwifruit, Prunes, & Fiber for Abdominal and Bowel Symptoms in US Patients With Chronic Constipation

NCT03569527

Chronic Constipation

COMPLETED NA

The Effect of Natural Carbonated Mineral Water Consumption on Gastrointestinal Transit and on Gut Microbiota in Subjects With Functional Constipation: A Randomized, Placebo-Controlled Pilot Trial

NCT05375487

Functional Constipation

UNKNOWN NA

Fibers and Gut Health

NCT02234518

Constipation

COMPLETED NA

Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

NCT02291354

Slow Transit Constipation

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome With Constipation Constipation-predominant Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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"

Group Type EXPERIMENTAL

kombucha-based beverage

Intervention Type 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

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Kombucha enriched with inulin, vitamins and flavours

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No