Clinical trial NCT06782880: Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation
Official title: Efficacy and Safety of Fecal Microbiota Transplantation for the Prevention of Early-onset Infectious Complications After Orthotopic Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fecal Microbiota Transplantation
Orthotopic Liver Transplantation
Multi-drug Resistant Bacteria
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for inclusion in the present study. Study enrollment will start after the favorable opinion of the Ethics Committee and the authorization by the General Manager of IRCCS AOUBO, in May 2023, indicatively, and will last 24 months.
Primary purpose: PREVENTION

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.

Detailed description: The study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list.

Enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation.

The intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. Fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. Gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. Moreover, clinical and microbiota assessments will be performed after liver transplantation. All other planned assessments are part of the normal course of care.

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.

Primary outcomes:
measure: To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.
timeFrame: At 6 months after OLT
Secondary outcomes:
measure: Incidence of adverse events after FMT
timeFrame: 3 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Giovanni Barbara, MD
role: PRINCIPAL_INVESTIGATOR
References: