NCT06782880 Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation
| NCT ID | NCT06782880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Fecal Microbiota Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2023-05-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.
Eligibility 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.
Contact & Investigator
Giovanni Barbara, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06782880 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Fecal Microbiota Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06782880 currently recruiting?
Yes, NCT06782880 is actively recruiting participants. Contact the research team at giovanni.barbara@unibo.it for enrollment information.
Where is the NCT06782880 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06782880 clinical trial?
NCT06782880 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Giovanni Barbara, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 144 participants.