Actively Recruiting
FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-12
36
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years
- Diagnosed with carbapenem-resistant Enterobacteriaceae (CRE) by rectal swab within 15 days before evaluation
- Able to undergo study procedures and provide informed consent
You will not qualify if you...
- Having active chronic gastrointestinal disorders
- History of previous colorectal surgery
- Presence of major comorbidities
- Currently pregnant or breastfeeding
- Having psychiatric disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Giovanni Cammarota
Roma, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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