FMT to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
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 reservoi
| Condition(s) | Enterobacteriaceae Infections, Multi-antibiotic Resistance |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 limite |
| Who can participate | Inclusion Criteria: * \>18 years; * CRE diagnosed with rectal swab \<15 days before evaluation; * Ability to undergo study procedures and to give informed consent. Exclusion Criteria: * Active chronic gastrointestinal disorders; * Previous colorectal surgery; * Major comorbidities; * Pregnancy/breastfeeding; * Psychiatric disorders. |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Locations | Roma, Italy |
| Start date | 2024-02-08 |
| NCT ID | NCT05791396 |
| Official listing | https://clinicaltrials.gov/study/NCT05791396 |