FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Enterobacteriaceae Infections, Multi-antibiotic Resistance

In brief

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

Key facts

Study ID

NCT05791396

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

36

Starts

2024-02-08

Expected to finish

2026-04-01

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years;
• CRE diagnosed with rectal swab <15 days before evaluation;
• Ability to undergo study procedures and to give informed consent.

You may not qualify if…

• Active chronic gastrointestinal disorders;
• Previous colorectal surgery;
• Major comorbidities;
• Pregnancy/breastfeeding;
• Psychiatric disorders.

Where it is running

• Giovanni Cammarota — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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