Fecal Microbiota Transplant (FMT) for Pouchitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Clinical improvement of pouchitis
研究概览
简要总结
This is a prospective, open label pilot study in which patients with symptoms of acute or chronic pouchitis will receive FMT therapy delivered via pouchoscopy. The investigators hypothesize that FMT is a safe and effective treatment for patients with pouchitis. Our aims our:
- To determine if symptoms of pouchitis can be successfully treated by Fecal Microbial Transplantation.
- To determine if endoscopic appearance of ileal pouch improves following treatment by Fecal Microbial Transplantation.
详细描述
This is a prospective, open label pilot study in which patients with symptoms of acute or chronic pouchitis will receive FMT therapy delivered via pouchoscopy.
Number of Subjects:
This study will aim to enroll approximately 30 patients with pouchitis.
Eligibility Criteria for FMT Group:
Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both acute and chronic pouchitis will be eligible for treatment with FMT. Patients eligible for FMT will include:
- •Patients with history of proctocolectomy with IPAA with pouchitis confirmed by endoscopy and pathology.
- •Concurrent therapies with mesalamine, immunomodulators, corticosteroids and biologic agents will be allowed to continue during study.
排除标准
- •Female patients who are pregnant.
- •Patients with severe immunosuppression (absolute neutrophil count < 1000 or CD4 count <200).
- •Patients with diagnosis of ileal Crohn's Disease.
- •Patients with untreated enteric infection.
- •Patients with fistulizing disease.
- •Patients with gastroparesis or dysphagia will not be eligible for the arm of the study allowing for administration of weekly capsules
研究组 & 干预措施
Pouchitis patients receiving FMT
Pouchitis patients receiving biologically active human fecal material sourced from OpenBiome.The physician will administer 250 mL of the fecal suspension in aliquots of 50-60 mL through the endoscope. The material will be delivered to the most proximal point of insertion.
干预措施: Biologically active human fecal material, OpenBiome (Drug)
结局指标
主要结局
Clinical improvement of pouchitis
时间窗: 4 weeks
In order to assess clinical improvement of pouchitis, patients will be scheduled for a 4 week post-FMT treatment clinic visit to ensure no adverse events have occurred and to assess patient symptoms. Patients will also complete a survey both before and after treatment to evaluate the efficacy of FMT treatment.
次要结局
- Mucosal healing(6 months)
研究者
Najwa Elnachef
Assistant Clinical Professor
University of California, San Francisco