Could a gut bug boost Crohn's treatment? new trial investigates
NCT ID NCT07415473
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a specific gut bacteria (Akkermansia muciniphila) to the standard drug infliximab helps heal the intestinal lining better than infliximab alone in people with Crohn's disease. About 400 adults with active Crohn's will be randomly assigned to one of two groups. The goal is to see if the combination leads to more complete healing of gut ulcers.
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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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
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 75 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: 1. Adult patients aged 18 to 75 years. 2. Documented diagnosis of Crohn's disease established at any time prior to screening by radiological, histological, or endoscopic evidence. 3. Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive). 4. Adequate cardiac, renal and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation. 5. Willingness and ability to provide written informed consent. 6. Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations. Exclusion Criteria: 1. Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening. 2. Use of systemic antibiotics or any probiotic preparation within 4 weeks prior to screening. 3. History of any intestinal resection or other Crohn's disease-related surgery. 4. History of or active chronic or recurrent infectious disease. 5. History of or current malignancy. 6. Pregnancy, lactation, or intention to become pregnant during the study period.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.