Not Yet RecruitingPhase 4

Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

400 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. 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.
✕. Pregnancy, lactation, or intention to become pregnant during the study period.

What they're measuring

Complete mucosal healing

Timeframe: From enrollment to the end of treatment at 26 weeks

Trial details

NCT IDNCT07415473

SponsorChinese Medical Association

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2029-03-31

View on ClinicalTrials.gov More Crohn's Diseases trials