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Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

NCT03061097 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2021-05-05

Study results available
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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.

Conditions

  • Antibiotic Resistant Strain

Interventions

BIOLOGICAL

Autologous fecal microbiota transplant (Auto-FMP Enema)

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.

OTHER

Placebo Enema Preparation

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

Sponsors & Collaborators

  • Boston Medical Center

    collaborator OTHER

  • Microbiome Health Research Institute

    lead OTHER

Principal Investigators

  • Majdi Osman, MD, MPH · Microbiome Health Research Institute, (d/b/a OpenBiome)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2018-12-19
Completion
2019-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061097 on ClinicalTrials.gov