Could bile acids explain why kids with colitis get more c. diff infections?
NCT ID NCT06228352
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study looks at bile acid profiles in children with ulcerative colitis (UC) who also have a C. difficile infection. Researchers want to see if changes in bile acids and gut bacteria make these children more vulnerable. They will compare three groups: children with UC flare-ups with or without C. diff, those in remission, and healthy kids. No treatments are given—just stool samples are collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could reveal why children with ulcerative colitis are more prone to C. difficile infections, pointing toward future preventive strategies.
- What could go wrong
- This is an observational study with only 80 participants, so findings may not apply broadly. It does not test any treatment, so direct patient benefits are not expected.
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.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2029
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.
Who is studied
Pediatric patients consulting or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital, with ulcerative colitis (UC) in flare-up with and without Clostridioides difficile infection (CDI), patients UC in remission and healthy controls.
- Ages
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Up to 17 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.
For everyone : Inclusion Criteria: * Pediatric patients (\<18 years) consultant or hospitalized in the Gastroenterology department of Necker-Enfants Malades Hospital. * Information and consent of parents and the patient Exclusion Criteria: * Patient who received antibiotic or antifungal treatment in the 4 weeks prior to inclusion. * Patients colonized by C. difficile. * Pregnant or breastfeeding young girl. * Refusal of the protocol by parents or patient. For group 1: Patients with active UC Inclusion criteria: * Patient with UC, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria. * UC in flare defined by a PUCAI score of between 35 and 65. Non-inclusion criteria: * Patient with IBD unclassified or Crohn's disease. * Patient with isolated proctitis (\<5 cm). * Colectomized patients. * Patients with sclerosing cholangitis associated with their UC or liver disease. Group 2: Patients in UC remission Inclusion criteria: * Patient with UC, whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria. * UC in remission defined by a PUCAI score \<10. Non-inclusion criteria: * Patient with IBD unclassified or Crohn's disease. * Patient with isolated proctitis (\<5 cm). * Colectomized patients. * Patients with sclerosing cholangitis associated with their UC or liver disease. Group 3: Healthy control subjects Inclusion criteria: \- Patients hospitalized for an endoscopic assessment to control for abdominal pain, gastroesophageal reflux or polyposis. Non-inclusion criteria: * Patient with chronic liver disease. * Patient with chronic digestive disease (celiac disease, IBD, chronic chronic).
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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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Hôpital Necker-Enfants Malades
RECRUITINGParis, 75015, France
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