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

NCT06782880 | Recruiting

• 2 other identifiers: FMT-OLTBando RF-2021-12373311
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Incidence of clinically severe infections (sepsis, severe sepsis, septic shock)

  At 6 months after OLT

Secondary Outcomes (1)

• Incidence of adverse events after FMT

  3 years

Study Arms (2)

Heterologous FMT

EXPERIMENTAL

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.

Procedure: Fecal microbiota transplantation (FMT)

Homologous FMT

PLACEBO COMPARATOR

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.

Procedure: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) 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.

Heterologous FMT; Homologous FMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Giovanni Barbara, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Barbara, MD

CONTACT

+390512144103; giovanni.barbara@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 20, 2025
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)