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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Irritable Bowel Syndrome With Constipation, Constipation-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: kombucha-based beverage


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention/kombucha-based beverage<br>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<br>* 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<br>* Other names: Kombucha enriched with inulin, vitamins and flavours;|
| No Intervention: Control<br>Subjects of this group will receive standard diet with similar quantity of water as in experimental group | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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specialized food product, kombucha, safety, efficacy, constipation, functional food