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RECRUITING
NCT05791396
PHASE1/PHASE2

FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Antibiotic resistance (AR) is a critical public health threat and one of the greatest challenges of the 21st century. In an estimate of 2019, nearly 700.000 infections and 33.000 attributable deaths from multi-drug-resistant bacteria (MDRB) have occurred in Europe in 2015. The gastrointestinal tract is a large reservoir for MDRB, and the gut microbiota can harbor a collection of AR genes, called gut resistome. Preliminary nonrandomized evidence suggests that fecal microbiota transplant (FMT) could be a promising treatment option to eradicate MDRB, but established evidence, as well as mechanisms that underpin this therapeutic pathway, are still unavailable. Leveraging our expertise in FMT (OU1), microbiome (OU2) and MDRB (OU3), we aim to evaluate the efficacy of FMT (from donors with limited presence of AR genes) in eradicating intestinal MDRB through a randomized controlled trial and identifying microbial features that are associated with clinical efficacy and clearance of AR genes

Official title: Efficacy and Mechanisms of Fecal Microbiota Transplantation to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-02-08

Completion Date

2026-04

Last Updated

2025-03-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

Donor - FMT

this intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT

OTHER

Placebo FMT

This intervention is represented by the administration, in the recipients' gut, of a placebo through colonoscopy

Locations (1)

Giovanni Cammarota

Roma, Italy