Faecal Microbiota Transplantation for Liver Cirrhosis
Recruiting
Phase 2Phase 3Interventional Study
Liver Cirrhosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
University of Aarhus · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* More than one or…
Inclusion Criteria:
* 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 Criteria:
* 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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