Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06782880

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-20

144

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age6518 years) patients listed for OLT for various etiologies.
  • Patient's consent to participate in the study
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

G

Giovanni Barbara, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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