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Fecal Microbiota Transplantation for Primary Clostridium Difficile Diarrhea

NCT02801656 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-29

No results posted yet for this study

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.

Conditions

  • Clostridium Difficile

Interventions

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

Sponsors & Collaborators

  • Memorial University of Newfoundland

    lead OTHER

Principal Investigators

  • Peter Daley, MD FRCPC · Memorial University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02801656 on ClinicalTrials.gov