Can a probiotic keep ulcerative colitis in check?
NCT ID NCT07751081
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial is testing whether a probiotic supplement called Colipral, which contains a specific strain of E. coli bacteria, can improve gut health in people with ulcerative colitis who are in remission but still have digestive issues. Participants will take either the supplement or a placebo for 60 days, then switch, so everyone gets both. The study will look at changes in gut bacteria, markers of inflammation, and symptoms to see if the probiotic helps maintain remission and ease discomfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a food supplement containing the probiotic strain Escherichia coli 5C LMG S-33222 (Colipral)
- What this could lead to
- If effective, this probiotic could help maintain remission and ease gut symptoms in people with ulcerative colitis, potentially improving quality of life.
- What could go wrong
- This is a small, early-stage trial, and the supplement may not significantly alter gut bacteria or symptoms. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedale - Univeristà Padova
Padova, Padova, 35128, Italy
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