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

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.

Timeline

Start

2012-07

Primary completion

2015-01

Completion

2015-03

Outcome

Met primary endpoint

paper clinical resolution was 75.0% for the frozen FMT group and 70.3% for the fresh FMT group PMID 26757463 ↗

paper P < .001 for noninferiority. PMID 26757463 ↗

Publications

• Lee CH, Steiner T, Petrof EO, Smieja M, Roscoe D, Nematallah A, Weese JS, Collins S, Moayyedi P, Crowther M, Ropeleski MJ, Jayaratne P, Higgins D, Li Y, Rau NV, Kim PT. Frozen vs Fresh Fecal Microbiota Transplantation and Clinical Resolution of Diarrhea in Patients With Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):142-9. doi: 10.1001/jama.2015.18098.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fresh FMT	Unknown	—	Rectal
Subject	Frozen-and-Thawed FMT	Unknown	—	Rectal

Indications