Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation
Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
IRCCS Azienda Ospedaliero-Universitaria di Bologna
144 participants
May 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Adult (age≥18 years) patients listed for OLT for various etiologies.
- Patient's consent to participate in the study
Exclusion Criteria10
- 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.
Interventions
To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06782880