Using fecal microbiota transplantation to eliminate drug-resistant bacteria from the gut
Official title: Efficacy and Mechanisms of Fecal Microbiota Transplantation to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05791396 · Data updated 2026-11-12
This study is testing whether a treatment called fecal microbiota transplantation can help people get rid of tough drug-resistant bacteria in their gut.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | February 8, 2024 |
| Main results expected | April 2026 |
| Study ends | April 2026 |
| Registry record updated | March 12, 2025 |
| Trial ID | NCT05791396 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old diagnosed with carbapenem-resistant Enterobacteriaceae within the last 15 days.
✕Probably not a fit
Patients with active chronic gastrointestinal disorders, previous colorectal surgery, or major comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) to eradicate intestinal colonization by carbapenem-resistant Enterobacteriaceae (CRE). The study aims to evaluate the efficacy of FMT from donors with limited antibiotic resistance genes in a randomized controlled setting. Participants will be monitored for clinical efficacy and the clearance of antibiotic resistance genes, with the goal of restoring healthy gut microbiota to combat multi-drug-resistant bacteria. The trial is designed to provide established evidence for FMT as a treatment option for infections caused by these resistant bacteria.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from infections caused by multi-drug-resistant bacteria.
How similar studies have gone: Preliminary nonrandomized evidence suggests that fecal microbiota transplantation could be effective in eradicating multi-drug-resistant bacteria, but this specific approach is still being evaluated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Giovanni Cammarota
Roma, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.