NCT05164861

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Vasily Isakov · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-01-31
• Completion: 2023-07-28
• First posted: 2021-12-21
• Last updated: 2023-09-06

Locations

1 site across 1 country: Russia