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.
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