ACTRN12622000797774尚未招募未知
Feasibility and Safety of Faecal Microbial Transplantation for Graft-Versus-Host Disease
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Recipient of allogeneic bone marrow transplantation
- •2. Clinical and Histological diagnosis of gastrointestinal Graft-versus-Host Disease from any site in the GI tract.
- •3. Steroid refractory (SR) and / or steroid dependent (SD) GVHD defined as;
- •- Progression after 3 days of 2mg/kg of Prednisone or equivalent.
- •- No change after 7 days of 2mg/kg of Prednisone or equivalent.
- •- Incomplete response (<50% reduction in stool volume) after 14 days of 2mg/kg of
- •Prednisone or equivalent.
- •- Recurrence on steroid taper when receiving >50mg of prednisolone per day.
- •4. Ability to provide voluntary informed consent
排除标准
- •1. Contraindication or inability to insert a naso-duodenal tube; including cytopenias which prevent safe insertion of naso-duodenal tube despite transfusional support.
- •2. Active uncontrolled bacterial, fungal or viral infections
- •3. Pregnancy or breast feeding
研究者
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