Using fecal microbiota transplantation to eliminate drug-resistant bacteria from the gut
Efficacy and Mechanisms of Fecal Microbiota Transplantation to Eradicate Intestinal Colonization by Carbapenem-resistant Enterobacteriaceae
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05791396 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with carbapenem-resistant Enterobacteriaceae within the last 15 days.
Not a fit: Patients with active chronic gastrointestinal disorders, previous colorectal surgery, or major comorbidities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma
- Giovanni Cammarota — Roma, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.