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

NCT ID: NCT06782880

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-05-31

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.

Conditions

Fecal Microbiota Transplantation; Orthotopic Liver Transplantation; Multi-drug Resistant Bacteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Heterologous FMT

Heterologous feces will be processed from routinely screened universal donors. Adult patients listed or being evaluated for enlistment for OLT for various etiologies are eligible for Fecal Microbiota Transplantation. Fecal material must be infused by enema or colonoscopy.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation (FMT)

Intervention Type: PROCEDURE

To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.

Homologous FMT

The control arm will undergo autologous FMT after enrollment. Autologous feces will be collected by each patient the day before each FMT in both study arms. This will guarantee adequate patients' stool collection in order to subsequently store the fecal samples for autologous FMT and ensure blinding.

Group Type: PLACEBO_COMPARATOR

Fecal microbiota transplantation (FMT)

Intervention Type: PROCEDURE

To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.

Interventions

Fecal microbiota transplantation (FMT)

To assess if heterologous FMT is more effective than autologous FMT in reducing the rate of major infection episodes within 6-months after OLT.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Barbara, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Barbara, MD

Role: CONTACT

giovanni.barbara@unibo.it

+390512144103

Facility Contacts

Giovanni Barbara, MD

Role: primary

giovanni.barbara@unibo.it

+390512144103

Other Identifiers

Bando RF-2021-12373311

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FMT-OLT

Identifier Type: -

Identifier Source: org_study_id