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.
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.
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.
Parallel
Infliximab
DrugPatients will receive infliximab alone administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.
Akkermansia muciniphila + Infliximab
DrugPatients will receive oral Akkermansia muciniphila once daily starting at Week 0. Concurrently, they will receive intravenous infliximab at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.
Complete mucosal healing
Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.
Endoscopic remission
Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables-ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis-in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Endoscopic response
Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%.
Clinical remission
Clinical remission is defined as Crohn's Disease Activity Index (CDAI) of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Clinical response
Clinical response is defined as CDAI decrease from Baseline of ≥100 points.
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Chinese Medical Association
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Shenzhen University General Hospital
Collaborator
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