Fecal Transplant for MDRO Decolonization

Not Applicable

• Conditions: Multi-antibiotic Resistance
• Interventions: Biological: Fecal Microbiota Transplantation (FMT)

• Registration Number: NCT04181112
• Lead Sponsor: University of British Columbia

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2019-11-04
• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-06
• Primary Completion: 2022-11
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal microbiota transplantation	Fecal Microbiota Transplantation (FMT)	-
Fecal microbiota transplantation with antibiotic pre-treatment	Fecal Microbiota Transplantation (FMT)	-

Primary Outcome Measures

Name	Time	Method
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.	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Vancouver Coastal Health - Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Providence Health Care - St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada