Clinical trial NCT02801656: Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea
Official title: Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Clostridium Difficile
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2016-06-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy: Cure of diarrhea without recurrence in intention to treat population
timeFrame: 56 days
measure: Adverse Events
timeFrame: 56 days
Secondary outcomes:
measure: Efficacy: Cure of diarrhea without recurrence in a per protocol population
timeFrame: 56 days
measure: Efficacy: cure of diarrhea in intention to treat and per protocol populations
timeFrame: 10 days
measure: Efficacy: time to cure of diarrhea
timeFrame: 56 days
measure: Efficacy: Health status questionnaire
timeFrame: 56 days
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Health Sciences Centre
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University
name: Peter Daley, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: