Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
Who is this study for? Patients with Liver Cirrhosis
What treatments are being studied? Fecal Microbiota Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Denmark
Department of Hepatology and Gastroenterology, Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Karen Louise Thomsen, PhD
karethom@rm.dk
+4526949260
Backup
Sidsel Støy, PhD
sidsel.stoy@clin.au.dk
+4561664565
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 220
Treatments
Experimental: Faecal microbiota transplantation
The patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines.
Placebo_comparator: Placebo
The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.
Related Therapeutic Areas
Sponsors
Collaborators: Sjælland University Hospital, Odense University Hospital, Aalborg University, Esbjerg Hospital - University Hospital of Southern Denmark, Aalborg University Hospital, Hvidovre University Hospital, Aarhus University Hospital
Leads: University of Aarhus