Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders

NCT07751081 | Not Yet Recruiting

• 1 other identifier: 6576/AO/26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

inflammatory bowel disease; ulcerative colitis; functional disorders; gut microbiota

Outcome Measures

Primary Outcomes (1)

• Microbiota gut composition

  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.

  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).

Secondary Outcomes (6)

• Fecal calprotectin levels

  T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B)

• Quality of life in patiets with inflammatory bowel disease

  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).

• Dietary habits

  T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)

• Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome

  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).

• Severity of gastrointestinal symptoms

  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).

Study Arms (2)

Dietary Supplement Group (Treatment A)

ACTIVE COMPARATOR

In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days

Dietary Supplement: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222

Placebo Group (Treatment B)

PLACEBO COMPARATOR

In this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days

Other: Placebo

Interventions

Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 DIETARY_SUPPLEMENT

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

Dietary Supplement Group (Treatment A)

Placebo OTHER

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

Placebo Group (Treatment B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Azienda Ospedale - Univeristà Padova

Padova, Padova, 35128, Italy

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Gastrointestinal Diseases; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of the main results and ending 5 years thereafter.
• Access Criteria: Requests must include a methodologically sound proposal and will be evaluated by the Principal Investigator and the Sponsor; data will be shared after approval of the proposal and signature of a data access agreement.

Locations

IT (1)