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Multi-Centre Trial of Fresh vs. Frozen-and-Thawed FMT for Recurrent CDI

NCT01398969 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2021-06-07

No results posted yet for this study

Summary

The goal of this study is to determine the outcome of patients with recurrent CDI treated with fresh FMT versus frozen-and-thawed FMT in a randomized controlled trial. The specific objectives are to evaluate the safety of both types of FMT and to compare the clinical response, treatment failure and relapse rate in patients treated with fresh FMT compared to those treated with frozen-and-thawed FMT; also to assess the functional health and well-being of patients in each arm using a validated tool. The metagenomics will also be conducted from the stool samples collected from select patients from each arm: pre and post treatment and the matching donors. The metagenomics data will be used to determine the bacteria which may have contributed to the cure of CDI.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Fresh FMT

Participants will receive fresh FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed

BIOLOGICAL

Frozen-and-Thawed FMT

Participants will receive frozen-and-thawed FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Kingston Health Sciences Centre

    collaborator OTHER

  • Queen's University

    collaborator OTHER

  • Vancouver General Hospital

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Christine Lee, MD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-01-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT01398969 on ClinicalTrials.gov