Clostridium Difficile
Conditions
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.
Interventions
BIOLOGICALFecal Microbiota Transplantation
Oral, encapsulated FMT
DRUGVancomycin
Vancomycin po 125 mg qid x 10 days
BIOLOGICALFecal Microbiota Transplantation Placebo
Matching placebo to FMT
Matching placebo to Vancomycin
Sponsors
Memorial University of Newfoundland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Adverse Events | 56 days | Number of participants with treatment-related adverse events as defined by the Medical Dictionary for Regulatory Activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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. |
| 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: Health status questionnaire | 56 days | — |
Countries
Canada
Outcome results
None listed