Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Memorial University of Newfoundland

Status and phase: Withdrawn; Phase 3

Conditions: Clostridium Difficile

Treatments: Biological: Fecal Microbiota Transplantation Placebo; Biological: Fecal Microbiota Transplantation; Drug: Vancomycin; Drug: Vancomycin Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02801656

MUN-02

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Fecal Microbiota Transplantation

Experimental group

Description:

Oral, encapsulated fecal microbiota transplantation

Treatment:

Drug: Vancomycin Placebo

Biological: Fecal Microbiota Transplantation

Vancomycin

Active Comparator group

Description:

125 mg po qid x 10 days

Treatment:

Drug: Vancomycin

Biological: Fecal Microbiota Transplantation Placebo