Using fecal microbiota transplantation to treat antibiotic-resistant infections
Faecal Microbiota Transplantation to Eradicate Gut Colonisation From Carbapenem-resistant Enterobacteriaceae: a Randomised Controlled Trial
This study is testing whether a treatment using healthy gut bacteria from donors can help people get rid of hard-to-treat infections caused by antibiotic-resistant germs.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT04759001 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of fecal microbiota transplantation (FMT) to eliminate carbapenem-resistant Enterobacteriaceae (CRE) from the gut. The study aims to compare the effectiveness of donor FMT against a placebo FMT in patients who are colonized with these multi-drug resistant bacteria. By restoring healthy gut microbiota, the trial seeks to enhance colonization resistance and reduce the risk of infections associated with CRE. The study is designed as a randomized controlled trial to provide robust evidence on the efficacy of this approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who are currently colonized with carbapenem-resistant Enterobacteriaceae.
Not a fit: Patients with other gastrointestinal infections, active gastrointestinal disorders, or those who have recently altered their gut microbiota through medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the prevalence of multi-drug resistant infections in patients, improving overall health outcomes.
How similar studies have performed: While there is limited evidence from case reports and a single early-terminated trial, the potential of FMT for treating multi-drug resistant bacteria remains largely untested in larger, well-designed studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 18 years old or older * Current evidence of gut colonisation (diagnosed with rectal swab) by CRE * Ability to give their consent to be included in the study. Exclusion criteria * Another known gastrointestinal infection apart from C. difficile infection * Known active gastrointestinal disorders (e.g. infectious gastroenteritis, coeliac disease, inflammatory bowel disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) * Previous colorectal surgery or cutaneous stoma * Food allergies * Current or recent (\<2 weeks) therapy with drugs that could possibly alter gut microbiota (e.g. antimicrobials, probiotics, proton pump inhibitors, immunosuppressants, metformin) * Decompensated heart failure or heart disease with ejection fraction lower than 30% * Severe respiratory insufficiency * Psychiatric disorders * Pregnancy * Unable to give informed consent
Where this trial is running
Rome
- Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluca Ianiro — Fondazione Policlinico Gemelli IRCCS
- Study coordinator: Gianluca Ianiro
- Email: gianluca.ianiro@hotmail.it
- Phone: 3381929859
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.