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A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

NCT02394275 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-10-26

Study results available
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Summary

The primary goal of this proposal is to study the outcome of patients with recurrent Clostridium Difficile Infection (CDI) treated with frozen Fecal Microbiota Transplantation (FMT) in an open-labelled controlled trial. The specific objectives are to evaluate the safety of FMT and to determine the clinical response, treatment failure and relapse rate in patients treated with frozen-and-thawed FMT; to assess the functional health and well-being of patients in each arm using the validated tool, and to determine the feasibility of providing standardized FMT in multiple centres across Canada, including community hospitals. 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

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

All eligible patients will receive fecal microbiota transplant

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-01
Primary Completion
2016-09-01
Completion
2019-10-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT02394275 on ClinicalTrials.gov