DRKS00010910招募中未知
Fecal microbiota transplantation in chronic active ulcerative colitis: influence of the donor microbiota.
Klinische Abteilung für GastroenterologieKlinik für Innere MedizinMedizinische Universität Graz0 个研究点目标入组 30 人开始时间: 2016年8月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 14 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Established diagnosis of UC
- •Active disease (total Mayo score > 4 and endoscopic subscore > 1)
- •Failure or intolerance of previous immunosuppressive therapy (AZA, 6-MP, MTX), or biologic therapy (anti-TNF therapy or anti-integrin therapy)
- •In case of concomitant medication stable dose during the whole course of trial and 8 weeks before start of the trial.
- •In case of concomitant steroid therapy stable dose of steroid therapy for at least 14 days, tapering of steroids of 2,5mg every second week is allowed.
- •Signed informed consent
排除标准
- •Pregnancy, coexisting infections with clostridium difficile, salmonella, shigella, campylobacter, yersinia, EHEC, severe coagulation disorders and anticoagulation treatment (except antiplatelet monotherapy, or low dose heparin), intravenous steroids, antibiotic or probiotic use during and 14 days prior to study entry, bile salt sequestrants during and 14 days prior to study entry, contraindication to lower endoscopy, untreated IBD associated dysplasia, any previous colectomy or Jpouch, decompensated liver cirrhosis known active malignancy (except for basal skin cancer, squamous cell skin cancer), received investigational new drug within 1 month before study entry, fever > 38.3 ºC
研究者
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