NL-OMON49333撤回2 期
Efficacy and Safety of Multiple Faecal Microbiota Transfers in Acute Pouchitis - FMT-pouchitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •IPAA for ulcerative colitis
- •Episode of acute pouchitis, defined as a PDAI >= 7, and endoscopic subscore of
- •History of at least one episode of pouchitis, which necessitated antibiotic
排除标准
- •- Pouchitis due to surgery related conditions (i.e. abscess, fistula. sinus of
- •the pouch), identified by endoscopic assessment of the pouch
- •- Crohn's Disease
- •- Patients with signs of severe systemic inflammation (at least two of the
- •following symptoms: temperature > 38.5 *C, tachycardia > 100 bpm (after
- •rehydration), systolic blood pressure < 100 mmHg).
- •- Patients with severe pouchitis on endoscopy who require immediate
- •intervention, based on the discretion of the endoscopist.
- •- Mechanical complications of the pouch (i.e. pouch stricture, pouch fistula)
- •- Diverting ileostomy
- •- Use of systemic antibiotic or probiotic therapy in the preceding 4 weeks.
- •- Use of concurrent anti-inflammatory drugs (i.e. thiopurines, anti-TNF,
- •corticosteroids, etc.)
研究者
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