Fecal Transplant for MDR Pathogen Decolonization
Terminated
- Conditions
- Multi-antibiotic Resistance
- Registration Number
- NCT02906774
- Lead Sponsor
- University of British Columbia
- Brief Summary
This is a proof-of-principle research study 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 by 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of the study will be the proportion of successfully decolonized patients out of all study patients evaluated, defined as the sustained elimination of a MDR target organism over a minimum of ≥ 2 study visits. 6 months
- Secondary Outcome Measures
Name Time Method Estimate the proportion of patients who become re-colonized following FMT. 6 months Determine the number of patients with treatment-related adverse events, as defined by the study adverse event questionnaire (including the Common Terminology Criteria for Adverse Events (v4.0)). 6 months
Trial Locations
- Locations (1)
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada