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FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Donor - FMT
this intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT
Placebo FMT
This intervention is represented by the administration, in the recipients' gut, of a placebo through colonoscopy
Locations (1)
Giovanni Cammarota
Roma, Italy