CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1 enrolled
Drug / intervention
Fecal microbiota transplantdrug
Likely dose
Fecal microbiota transplant 150mLfrom 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/NCT03367910
NCT03367910Phase 2Completed
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Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms

Washington University School of Medicine·interventional·Posted Dec 11, 2017·Updated Mar 18, 2022

In Brief

A Phase 2 clinical trial evaluating Fecal microbiota transplant for Urinary Tract Infections. Completed, enrolled 1 participant across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and impact of fecal microbiota transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO) colonization of patients with a history of recurrent MDRO UTIs. This is an open label phase 1-2 study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention, University of Pennsylvania, Duke University, Rush University, Rebiotix Inc.

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2017
Enrollment StartFeb 8, 2018
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.6 years ago

Interventions

Fecal microbiota transplantdrug

150mL of FMT product RBX2660 delivered via enema