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Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
Sponsor: University of Padova
Summary
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI. The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI. The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
Official title: Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-09-01
Completion Date
2028-03
Last Updated
2026-08-07
Healthy Volunteers
No
Conditions
Interventions
Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222
2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
Placebo
2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
Locations (1)
Azienda Ospedale - Univeristà Padova
Padova, Padova, Italy