Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
Not applicable · Testing Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 · 1 site · University of Padova
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222 (a dietary supplement) to improve how care is delivered. Condition(s) listed: Inflammatory Bowel Disease, Ulcerative Colitis Type and Functional Disorder of Gastrointestinal Tract.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 4 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2026-09-01 (planned).
- Main results expected around 2028-03 (estimate from the record).
- 1 study site listed in Italy.
Main thing being measured
- 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…)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease, Ulcerative Colitis Type; Functional Disorder of Gastrointestinal Tract |
| Lead sponsor | University of Padova |
| Enrollment | 50 (estimated) |
| Start date | 2026-09-01 |
| Primary completion (est.) | 2028-03 |
| First posted | 2026-08-07 |
| Last updated | 2026-08-07 |
| 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 |
| ClinicalTrials.gov ID | NCT07751081 |
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 - Placebo (Other)
2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedale - Univeristà Padova | Padova, Padova | Italy |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.