Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Endoscopic remission rate
研究概览
简要总结
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- •IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- •Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- •Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- •Voluntary participation and signing of informed consent.
- •Adults aged 18-
- •Can tolerate oral enterobacteria transplantation capsule treatment.
排除标准
- •The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
- •IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
- •Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
- •Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
- •Voluntary participation and signing of informed consent.
- •Adults aged 18-
- •Can tolerate oral enterobacteria transplantation capsule treatment.
研究组 & 干预措施
Biological agent +FMT
47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety.
干预措施: Fecal microbiota transplantation (Procedure)
Biological agent
47 patients were treated with biological agents. All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety.
干预措施: infliximab (Drug)
Biological agent +FMT
47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety.
干预措施: infliximab (Drug)
结局指标
主要结局
Endoscopic remission rate
时间窗: 14th and 52nd week after joining the group.
UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)\<3 or no ulcer.
Clinical remission rate
时间窗: 14th and 52nd week after joining the group.
UC is defined as Mayo score ≤2, and no single score \> 1; CD is defined as CDAI (Crohn's disease activity index) \< 150.
次要结局
未报告次要终点
研究者
Chen QiYi
Director of department
Shanghai 10th People's Hospital