Can a probiotic enema heal the gut lining in ulcerative colitis?
NCT ID NCT07724990
First seen Jul 24, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This pilot study tests whether a specific probiotic, given as a rectal enema, can improve gut health in people with mild-to-moderate ulcerative colitis. Researchers will measure changes in the gut microbiome and signs of rectal healing. The trial enrolls 20 adults aged 18 to 80 with a confirmed diagnosis of ulcerative colitis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a specific probiotic given as a rectal enema
- What this could lead to
- If it works, this could offer a new, targeted way to manage ulcerative colitis by restoring healthy gut bacteria.
- What could go wrong
- This is a very early, small pilot study with only 20 participants and no comparison group, so results may not be generalizable. The probiotic is experimental and its safety and effectiveness are not yet established.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
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 80 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men or women 18 to 80 years of age at the time of consent * Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening * Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore \>1 based on endoscopic evaluation performed during screening phase * Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening * Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments. Exclusion Criteria: * concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded. * Intolerance to topical therapy (enemas) * Allergy to A. muciniphila or any other component of the IP * Crohn's disease or inflammatory bowel disease unclassified (IBD-U) * Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period. * Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period. * Subject who received fecal microbial transplantation within 3 months prior to Baseline. * Subjects with the following chronic or active infections: * Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study * Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice, * Are infected with human immunodeficiency virus (HIV), * Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study. * Pregnancy and breastfeeding
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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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Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
RECRUITINGRoma, RM, 00146, Italy
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