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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
7
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.
The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
Boston University - Boston Medical Center nursing home consortium
Boston, Massachusetts, United States
Number of Participants With Adverse Events (NIH Grade ≥2) at Day 7 After Randomization
Number of participants with NIH Grade ≥2 adverse events at Day 7 after randomization.
Time frame: Day 7 after randomization
Number of Patients With Clearance of Antibiotic Resistant Bacteria (ARB)
Number of patients with clearance of ARB among patients colonized at Day 28 by Polymerase Chain Reaction (PCR) assay or culture-based assay. ARBs are: Carbapenem-resistant Enterobacteriaceae (CRE) by PCR or culture assay, Extended spectrum beta-lactamase (ESBL)-producing organisms by PCR or culture assay, Vancomycin-resistant enterococci (VRE) by PCR or culture assay, or Clostridium difficile by PCR
Time frame: Day 28 after randomization
Number of Participants Who Develop Any ARB-associated Infections
Number of participants who develop any ARB-associated infections following autologous FMT at Day 3, Day 7, Day 28, and Month 6
Time frame: Day 3, Day 7, Day 28, Month 6
Number of Participants With NIH Grade ≥2 AEs at Day 28 and Month 6
Number of participants with NIH Grade ≥2 adverse events (intermediate at Day 28 and long-term at Month 6) following autologous FMT.
Time frame: Day 28, Month 6
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