Using fecal microbiota transplantation to prevent infections after liver transplantation
Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
This study is testing if a special treatment using healthy stool can help prevent infections in people getting a liver transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06782880 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of heterologous fecal microbiota transplantation (FMT) to reduce the risk of multi-drug resistant bacteria (MDRB) infections in patients undergoing orthotopic liver transplantation (OLT). It is a double-blind, single-center, randomized controlled trial where adult patients on the liver transplant list will be randomly assigned to receive either FMT from a healthy donor or their own fecal material. The study will assess the composition of fecal microbiota and gut permeability before and after the transplantation process, along with clinical evaluations post-surgery. The goal is to determine if FMT can effectively decolonize MDRB and restore a healthier gut microbiome in these patients.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are listed for liver transplantation.
Not a fit: Patients with certain conditions such as previous total colectomy, active infections, or those on antimicrobial agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce infection rates and improve outcomes for liver transplant patients.
How similar studies have performed: While the use of FMT is gaining traction, this specific application for preventing infections post-liver transplantation is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (age≥18 years) patients listed for OLT for various etiologies. * Patient's consent to participate in the study Exclusion Criteria: * Previous total colectomy * Pregnancy or breastfeeding * Patients on oral or intravenous antimicrobial agents * HIV positive and not well controlled on antiretroviral therapy, or CD4+ \<200/ mm3 * Active SARS-CoV-2 infection * Neutropenia \<0.5X10\^9/L * Toxic megacolon * Contraindications to colonoscopy * Any conditions for which, according to the physician, FMT endangers the patient's health * History of hypersensitivity to macrogol contained in bowel preparations.
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Giovanni Barbara, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Giovanni Barbara, MD
- Email: giovanni.barbara@unibo.it
- Phone: +390512144103
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.