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临床试验/NCT07415473
NCT07415473尚未招募4 期

A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

Chinese Medical Association0 个研究点目标入组 400 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
400
主要终点
Complete mucosal healing

研究概览

简要总结

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.

详细描述

This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy of Akkermansia muciniphila combined with infliximab in patients with Crohn's disease.

Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses combined with Akkermansia muciniphila supplementation administered once daily or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26, and the secondary endpoint include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Akkermansia muciniphila + Infliximab

Experimental

干预措施: Akkermansia muciniphila + Infliximab (Drug)

Infliximab alone

Active Comparator

干预措施: Infliximab (Drug)

结局指标

主要结局

Complete mucosal healing

时间窗: From enrollment to the end of treatment at 26 weeks

Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.

次要结局

  • Endoscopic remission(From enrollment to the end of treatment at 26 weeks)
  • Endoscopic response(From enrollment to the end of treatment at 26 weeks)
  • Clinical remission(From enrollment to the end of treatment at 26 weeks)
  • Clinical response(From enrollment to the end of treatment at 26 weeks)

研究者

申办方类型
Network
责任方
Principal Investigator
主要研究者

Sheng-hong Zhang

Chief Physician, Professor

Chinese Medical Association

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