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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

NCT07751081 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-07

No results posted yet for this 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.

Conditions

  • Inflammatory Bowel Disease, Ulcerative Colitis Type
  • Functional Disorder of Gastrointestinal Tract

Interventions

DIETARY_SUPPLEMENT

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

OTHER

Placebo

2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751081 on ClinicalTrials.gov