RecruitingPhase 1Phase 2NCT05791396

FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

36 participants

Start Date

Feb 8, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria3

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

Exclusion Criteria5

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

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Interventions

BIOLOGICALDonor - FMT

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

OTHERPlacebo FMT

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


Locations(1)

Giovanni Cammarota

Roma, Italy

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NCT05791396


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