NCT07415473Not yet recruitingPhase 4
Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease
A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
This study aims to evaluate whether the combination of Akkermansia muciniphila with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 10 Feb 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Chinese Medical Association
- Diseases
- Crohn's disease
- NCT number
- NCT07415473
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 400
- From 1 Apr 2026 to the primary completion date, 31 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.
- Use of systemic antibiotics or any probiotic preparation within 4 weeks prior to screening.
Other illness
- History of any intestinal resection or other Crohn's disease-related surgery.
- History of or active chronic or recurrent infectious disease.
- History of or current malignancy.
Other
- Pregnancy, lactation, or intention to become pregnant during the study period.
Who the study is looking for
- Adult patients aged 18 to 75 years.
- Documented diagnosis of Crohn's disease established at any time prior to screening by radiological, histological, or endoscopic evidence.
- Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).
- 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.
- Willingness and ability to provide written informed consent.
- Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.