Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Clostridium difficile associated diarrhea (CDAD) is a significant cause of morbidity and mortality, caused by loss of healthy gut flora. Conventional treatment uses antibiotics to kill Clostridium difficile. A novel treatment uses replacement of gut flora by fecal microbiota transplant (FMT). Randomized trials have established safety and efficacy of FMT in recurrent CDAD, but no trial has used FMT for primary CDAD. This study will randomize patients to oral encapsulated FMT or oral Vancomycin.
详细描述
Patients with primary CDAD will be approached for consent and randomized equally to two arms: oral FMT with oral Vancomycin placebo, or oral FMT placebo with oral Vancomycin. FMT will be prepared from anonymous donors screened according to Health Canada guidelines and stored frozen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization
排除标准
- •pregnancy, previous stool test positive within 12 months, toxic megacolon or ileus, already received >4 doses of treatment for current episode, inflammatory bowel disease, gastrointestinal surgery within 90 days of randomization (except appendectomy or cholecystectomy), documented aspiration of gastric contents within 90 days of randomization, requirement for treatment with oral probiotics, opiates, loperamide or diphenoxylate during the study duration, anticipated use of antibiotics for any reason during the study duration, known non-CDAD concurrent gastrointestinal infection, concurrent enrollment in another clinical trial for any reason, intolerance or hypersensitivity to Vancomycin, anaphylactic reaction to any food, current induction chemotherapy, HIV infection with Cluster of Differentiation 4 (CD4) count <200, or any medical or non-medical condition considered by the investigator to preclude participation.
研究组 & 干预措施
Vancomycin
125 mg po qid x 10 days
干预措施: Vancomycin (Drug)
Fecal Microbiota Transplantation
Oral, encapsulated fecal microbiota transplantation
干预措施: Vancomycin Placebo (Drug)
Fecal Microbiota Transplantation
Oral, encapsulated fecal microbiota transplantation
干预措施: Fecal Microbiota Transplantation (Biological)
Vancomycin
125 mg po qid x 10 days
干预措施: Fecal Microbiota Transplantation Placebo (Biological)
结局指标
主要结局
Adverse Events
时间窗: 56 days
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Efficacy: Cure of diarrhea without recurrence in intention to treat population
时间窗: 56 days
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period. Recurrence is defined as 3 or more bowel motions within one day during the follow-up period.
次要结局
- Efficacy: Health status questionnaire(56 days)
- Efficacy: Cure of diarrhea without recurrence in a per protocol population(56 days)
- Efficacy: time to cure of diarrhea(56 days)
- Efficacy: cure of diarrhea in intention to treat and per protocol populations(10 days)
研究者
Peter Daley
Assistant Professor
Memorial University of Newfoundland