CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 7 enrolled
Drug / intervention
Autologous fecal microbiota transplant (Auto-FMP Enema) +1 morebiological
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/NCT03061097
NCT03061097Phase 1Completed
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Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria

Microbiome Health Research Institute·interventional·Posted Feb 23, 2017·Updated May 5, 2021

In Brief

A Phase 1 clinical trial evaluating Autologous fecal microbiota transplant (Auto-FMP Enema) and Placebo Enema Preparation for Antibiotic Resistant Strain. Completed, enrolled 7 participants across 1 site.

Detailed Summary

This study, a Randomized controlled trial of Autologous microbiome reconstitution to prevent Colonization by antibiotic rEsistant bacteria (RACE), seeks to investigate the safety, feasibility and the role of autologous fecal microbiota transplantation (FMT) for the prevention of antibiotic resistant bacteria (ARB) through microbiome restoration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntibiotic Resistant Strain
CountriesUnited States
CollaboratorsBoston Medical Center

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartJul 10, 2017
Primary CompletionDec 19, 2018
Study CompletionJun 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago

Interventions

Autologous fecal microbiota transplant (Auto-FMP Enema)biological

FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.

Placebo Enema Preparationother

The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.