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Clinical Trials/NCT04181112
NCT04181112
Unknown
Not Applicable

Fecal Microbiota Transplantation (FMT) for Intestinal Decolonization of Multidrug-resistant Opportunistic Pathogens

University of British Columbia2 sites in 1 country90 target enrollmentNovember 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multi-antibiotic Resistance
Sponsor
University of British Columbia
Enrollment
90
Locations
2
Primary Endpoint
The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.
Last Updated
4 years ago

Overview

Brief Summary

This is a trial designed to determine whether fecal microbiota transplantation (FMT) can eliminate highly drug-resistant bacteria from the intestinal tract of renal transplant patients. The primary goal of this study is to test whether oral gut decontamination followed by FMT using enema delivery will result in decolonization of the intestinal tract of renal transplant patients shortly after solid organ transplantation, thereby preventing difficult to treat post-transplant infections.

Detailed Description

Contact the study principal investigator for the study protocol.

Registry
clinicaltrials.gov
Start Date
November 4, 2019
End Date
November 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amee Manges

Associate Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The elimination of the target multi-drug resistant organism (MDRO), using culture and molecular test-based screening of recipient stool, at both the 14 and 30 days post-FMT.

Time Frame: 3 years

Secondary Outcomes

  • Compare proportions, type and timing of adverse events post-FMT(3 years)
  • Proportions of recolonization over 180 days(3 years)
  • Timing of recolonization over 180 days(3 years)

Study Sites (2)

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