Prevention of Pouchitis With Short-Chain Fructooligosaccharide Therapy, A Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
研究概览
简要总结
The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- •Crohn's disease.
- •Perianal disease (including abscess, fissure, or stricture)
- •Concurrent treatment for IBD or pouchitis
研究组 & 干预措施
Maltodextrin
4 chews (maltodextrin) daily for 12 months
干预措施: Maltodextrin (Drug)
Short-Chain Fructooligosaccharide
4 chews (8.0 g scFOS) orally per day for 12 months
干预措施: Short-Chain Fructooligosaccharide (Drug)
结局指标
主要结局
Mean Change in Pouchitis Disease Activity Index (PDAI) at One Year
时间窗: baseline, 1 year
In the PDAI, an overall score is calculated from three separate six-point scales comprising of clinical symptoms, endoscopic findings and histological changes. The PDAI incorporates histological features of acute inflammation, and establishes a cut-off of seven for differentiation between 'pouchitis (≥7 points) and 'no pouchitis' (\<7 points).
次要结局
未报告次要终点
研究者
Laura E. Raffals, M.D
Assistant Professor of Medicine
Mayo Clinic