Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 75Years
All Genders
ID04932577

Faecal Microbiota Transplantation to Prevent Complications, Progression, and Mortality in Liver Cirrhosis

Led by University of Aarhus · Updated on 2025-01-24

220

Participants Needed

1

Research Sites

308 weeks

Total Duration

On this page

Sponsors

U

University of Aarhus

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of faecal microbiota transplantation (FMT) on patients with liver cirrhosis, specifically looking at complications, disease progression, and mortality. This study aims to explore how changing the gut microbiota with FMT impacts gut barrier function, systemic inflammation, and immune function. It is a Phase 2/3 clinical trial involving patients admitted with acute decompensation of liver cirrhosis. Participants will be randomly assigned to one of two groups: one group receives three applications of FMT, and the other group receives a placebo treatment. Following these treatments, all participants will be monitored and followed for one year to observe disease progression and changes in their gut microbiota and immune responses. During the study, patients will undergo regular assessments to track disease status, gut microbiota composition, gut barrier integrity, and immune function. The main outcome measured is the time until death or a new episode of acute decompensation that requires intervention, with follow-up lasting one year. Safety and effectiveness will be closely monitored throughout the study period.

CONDITIONS

Official Title

Faecal Microbiota Transplantation for Liver Cirrhosis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Diagnosis of liver cirrhosis with Child-Pugh score less than or equal to 12
  • Acute decompensation requiring intervention such as ascites, gastrointestinal bleeding, infections leading to progressive liver failure, hepatic encephalopathy, or alcoholic hepatitis
Not Eligible

You will not qualify if you...

  • More than one organ failure defined by CLIF-SOFA score
  • Untreated malignancy except non-melanoma skin cancer
  • Untreated viral hepatitis
  • HIV infection
  • Inflammatory bowel disease
  • Celiac disease
  • Clostridioides difficile infection
  • Pregnancy
  • Unable to participate based on medical judgment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Denmark, 8200

Actively Recruiting

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Research Team

K

Karen Louise Thomsen, PhD

S

Sidsel Støy, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol: a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis.

Sidsel Støy, Lotte Lindgreen Eriksen, Johanne Sloth Lauszus...

https://pubmed.ncbi.nlm.nih.gov/39938959