RecruitingPhase 2Phase 3NCT04932577

Faecal Microbiota Transplantation for Liver Cirrhosis

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


Sponsor

University of Aarhus

Enrollment

220 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • Age 18-75 years
  • Liver cirrhosis with Child-Pugh ≤ 12
  • Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis)

Exclusion Criteria9

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

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Interventions

BIOLOGICALFaecal microbiota transplantation

All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.

BIOLOGICALPlacebo

Placebo


Locations(1)

Department of Hepatology and Gastroenterology, Aarhus University Hospital

Aarhus, Denmark

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NCT04932577


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