Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
- Conditions
- Clostridium Difficile
- Interventions
- Biological: Fecal Microbiota TransplantationBiological: Fecal Microbiota Transplantation Placebo
- Registration Number
- NCT02801656
- Lead Sponsor
- Memorial University of Newfoundland
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to randomization, positive stool test within 72 hours of randomization
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vancomycin Vancomycin 125 mg po qid x 10 days Fecal Microbiota Transplantation Fecal Microbiota Transplantation Oral, encapsulated fecal microbiota transplantation Vancomycin Fecal Microbiota Transplantation Placebo 125 mg po qid x 10 days Fecal Microbiota Transplantation Vancomycin Placebo Oral, encapsulated fecal microbiota transplantation
- Primary Outcome Measures
Name Time Method Adverse Events 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 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.
- Secondary Outcome Measures
Name Time Method Efficacy: Health status questionnaire 56 days Efficacy: Cure of diarrhea without recurrence in a per protocol population 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.
Efficacy: time to cure of diarrhea 56 days Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Efficacy: cure of diarrhea in intention to treat and per protocol populations 10 days Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Trial Locations
- Locations (1)
Health Sciences Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada