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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Oral, encapsulated FMT
Vancomycin po 125 mg qid x 10 days
Matching placebo to FMT
Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada
Efficacy: Cure of diarrhea without recurrence in intention to treat population
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.
Time frame: 56 days
Adverse Events
Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities.
Time frame: 56 days
Efficacy: Cure of diarrhea without recurrence in a per protocol population
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.
Time frame: 56 days
Efficacy: cure of diarrhea in intention to treat and per protocol populations
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Time frame: 10 days
Efficacy: time to cure of diarrhea
Cure is defined as less than 3 bowel motions per day for 2 consecutive days during the 10 day treatment period.
Time frame: 56 days
Efficacy: Health status questionnaire
Time frame: 56 days
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Matching placebo to Vancomycin