NCT02801656

Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

Fecal Microbiota Transplantation for Primary Therapy in Clostridium Difficile Diarrhea - A Placebo-blinded Randomized Clinical Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Memorial University of Newfoundland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation	Oral, encapsulated FMT
DRUG	Vancomycin	Vancomycin po 125 mg qid x 10 days
BIOLOGICAL	Fecal Microbiota Transplantation Placebo	Matching placebo to FMT
DRUG	Vancomycin Placebo	Matching placebo to Vancomycin

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2016-06-16
• Last updated: 2022-04-29

Locations

1 site across 1 country: Canada