NCT03061097

Autologous Fecal Microbiota Transplantation to Prevent Antibiotic Resistant Bacteria Colonization

Randomized Controlled Trial of Autologous Microbiome Reconstitution to Prevent Colonization by Antibiotic rEsistant Bacteria

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Microbiome Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Note: The Protocol and Statistical Analysis Plan document contains modifications from what is on file at the FDA to reflect redactions and formatting requirements for public posting on ClinicalTrials.gov

Conditions

• Antibiotic Resistant Strain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-10
• Primary completion: 2018-12-19
• Completion: 2019-06-18
• First posted: 2017-02-23
• Last updated: 2021-05-05
• Results posted: 2020-12-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study