CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 1 enrolled
Drug / intervention
Fecal microbiota transplantation (FMT)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02312986
NCT02312986Phase 1Completed
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Use of Fecal Microbiota Transplantation (FMT) to Reverse Multi-Drug Resistant Organism Carriage

Washington University School of Medicine·interventional·Posted Dec 9, 2014·Updated Feb 24, 2021

In Brief

A Phase 1 clinical trial evaluating Fecal microbiota transplantation (FMT) for Infection With Multi-drug Resistant Organisms. Completed, enrolled 1 participant.

Detailed Summary

This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infections due to organisms of likely enteric origin. FMT will be performed on subjects with a history of at least three recurrent infections due to MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities are available. The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will be able to prevent additional recurrences of infections due to MDRO by suppressing or reversing enteric colonization with MDRO.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection With Multi-drug Resistant Organisms
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 9, 2014
Enrollment StartAug 1, 2015
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 11.6 years ago

Interventions

Fecal microbiota transplantation (FMT)biological

Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.