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

Phase 2

Completed

• Conditions: Clostridium Difficile Infection
• Interventions: Biological: Fresh FMT; Biological: Frozen-and-Thawed FMT

• Registration Number: NCT01398969
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-21
• Study Start: 2012-07
• Primary Completion: 2015-01
• Status Verified: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2021-06-02
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh FMT	Fresh FMT	Participants in this arm will receive Fresh FMT via rectal administration. They will be followed for 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.
Frozen-and-Thawed FMT	Frozen-and-Thawed FMT	Participants in this arm will receive Frozen-and-Thawed FMT via rectal administration. They will be followed 13 weeks to assess the cure or recurrence of CDI. All other procedures between the two arms will be identical.

Primary Outcome Measures

Name	Time	Method
The evaluation of the safety of HBT	13 Weeks post HBT	Assessment for adverse reactions in each study group by history, physical examination, blood work at baseline, day 12, week 5 and at completion (week 13) of the study period.
To determine the cure rate without recurrence of CDI at 13 weeks from the last HBT.	13 Weeks post HBT

Secondary Outcome Measures

Name	Time	Method
To determine the relapse rate of clinical and laboratory evidence of CDI within the 13-week study period in participants treated with fresh HBT in comparison to frozen thawed HBT.	13 Weeks post HBT
Assessment of the functional health and well-being of patients	Up to 1 year	Patients will be asked to fill in the self-administered Health Survey at baseline, week 5, week 13 and 1 year from last HBT

Trial Locations

Locations (4)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Vancouver Coastal Health (VCHRI/VCHA) - Diamond Health Care Centre and Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada