Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
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
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion criteria:
* Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
* Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months
* Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
* Male/female
* Age in the range 18-70 years
* Subjects capable of conforming to the study protocol
* Subjects who have given their free and informed consent
Exclusion criteria:
* History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
* Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
* Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
* Females of childbearing potential, in the absence of effective contraceptive methods
* Subjects who become unable to conform to protocol
* Recent history or suspicion of alcohol abuse or drug addiction
* Indication for the initiation of a new drug therapy during the study
* History of current or recent antibiotic or probiotics use within the last 30 days
* Subjects who are treated with antibiotics
Primary outcome measure(s)
Microbiota gut composition — T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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