Faecal Microbiota Transplantation for Liver Cirrhosis

  • STATUS
    Recruiting
  • End date
    May 31, 2027
  • participants needed
    220
  • sponsor
    University of Aarhus
Updated on 17 November 2021
ascites
hepatitis
encephalopathy

Summary

The purpose is to investigate the effect of fecal microbiota transplantation (FMT)on complications, progression, and mortality of cirrhosis. Further, the investigators want to examine the impact of FMT on gut barrier function, systemic inflammation, and immune responses.

Description

Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so called episodes of decompensation. In this study we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as a faecal microbiota transplantation (FMT). In this this study we will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT in these patients. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.

Details
Condition liver cirrhosis, LIVER DISEASE, Liver Disorders, Hepatic Fibrosis, Cirrhosis, hepatic cirrhosis, Liver Disease
Treatment Placebo, Faecal microbiota transplantation
Clinical Study IdentifierNCT04932577
SponsorUniversity of Aarhus
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18-75 years
Liver cirrhosis with Child-Pugh score 7-12
Hospital admission due to acute decompensation (ascites, gastrointestinal bleeding, bacterial infections, hepatic encephalopathy, alcoholic hepatitis)
Maximum of 1 organ failure defined by CLIF-SOFA score

Exclusion Criteria

Untreated malignancy apart from hepatocellular carcinoma within the Milan criteria or non-melanoma skin cancer
Untreated viral hepatitis
HIV
Inflammatory bowel disease
Celiac disease
Pregnancy
Unable to participate based on medical judgement
Clear my responses

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