Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
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.
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.
Inclusion Criteria:

 -  life expectancy > 3 months, 3 or more unformed stools in 24 hours prior to
 randomization, positive stool test within 72 hours of randomization

 Exclusion Criteria:

 -  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.