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Inclusion of patients concluded in the fourth GALAXY study

19.01.2021

It was a very happy SYN-ALD team at Odense University that last week finalised the inclusion of patients in the SYN-ALD study. In the SYN-ALD we investigate the role of probiotics/synbiotics on gut microbiota and particularly gut dysbiosis seen in liver disease. We hypothesize that the gut microbiota and its metabolites are major drivers of fibrosis in human liver disease and that modulating the intestinal flora by Profermin®  will halter the disease.

Study design

The patients in SYN-ALD are randomized 1:1 to receive Profermin® versus Fresubin® for 6 months. The randomisation will be stratified according to whether patients are abstaining or have an ongoing use of alcohol at inclusion. Outcome assessment of the 2 liver biopsies will be performed by a pathologist blinded for treatment group allocation.

Background for the SYN-ALD study 

Mortality from alcoholic liver cirrhosis is on the rise and currently, the only treatment for
fibrotic end-stage liver disease is liver transplantation, which is only available for a minority of patients. Therefore, there is a need for anti-fibrotic treatment strategies to slow down fibrogenesis, preserve liver function and reduce the burden on health care systems.
Probiotics have been shown to have several beneficial effects on intestinal function. The beneficial effects of probiotics in alcoholic liver disease are supported by several laboratory results and studies have shown their potential in animal models. But we still lack evidence for an effect of synbiotics.

Photo Profermin team 

Photo Johanne Kragh Hansen
Johanne Kragh Hansen, MD, Study Responsible

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