Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation

Recruiting now · Not applicable

Conditions studied: Fecal Microbiota Transplantation, Orthotopic Liver Transplantation, Multi-drug Resistant Bacteria

In brief

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.

Key facts

Study ID

NCT06782880

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

144

Starts

2023-05-01

Expected to finish

2026-05-31

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult (age≥18 years) patients listed for OLT for various etiologies.
• Patient's consent to participate in the study

You may not qualify if…

• 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 it is running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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