4500 IBD patients enrolled in quest for early warning biomarkers
NCT ID NCT07172945
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This observational study will follow 4500 adults with Crohn's disease or ulcerative colitis to identify biological markers—such as gut bacteria patterns—that predict disease progression and complications. Researchers will collect blood, stool, saliva, and tissue samples during routine care. The goal is to better understand why IBD behaves differently in each person and to improve treatment decisions.
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 study could identify early warning signs of disease worsening or treatment failure, helping doctors personalize care for IBD patients.
- What could go wrong
- This is an observational study, not a treatment trial. It may not lead to immediate changes in care, and findings may take years to confirm or apply in practice.
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 4,500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Nov 2040
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: For all patients and control subjects * Person able to give free and informed consent. * Age ≥ 18 years. * Beneficiary of a social protection scheme or entitled person (excluding AME). * Consultation in the Gastroenterology and Nutrition Department of Saint-Antoine Hospital Patients with IBD : \- Patients with Crohn's disease or haemorrhagic rectocolitis with a diagnosis established or confirmed in the Gastroenterology and Nutrition Department at Saint-Antoine Hospital. Microbiota control' subjects: \- Healthy subjects seen in consultation as a preventive measure or as part of stool donations for FMT. Endoscopy control' subjects: \- Subjects with a medical indication for digestive endoscopy with biopsies: * For upper endoscopy: moderate upper digestive symptoms such as epigastralgia or pyrosis * For colonoscopy: moderate digestive symptoms suggestive of irritable bowel syndrome or screening for colorectal cancer. Exclusion Criteria: For all patients and control subjects * Subjects under guardianship, curatorship or safeguard of justice. * Subjects who do not speak French. IBD patients: \- Colon preparation within 6 weeks before stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards). Endoscopy control' and "microbiota control" subjects: * Subject suffering from a chronic disease * Antibiotics taken in the 6 weeks prior to endoscopy * Antibiotics or colonic preparation taken within 6 weeks prior to stool sampling (stool samples may be taken either before colonoscopy or at least 6 weeks afterwards).
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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 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.
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Other studies related to the condition(s) this trial covers.
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- Could your Donor's gut bacteria decide whether a stool transplant works?
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