Last patient – last visit in GALAXY RCT
In August, a very important milestone was reached in the RCT SYN-ALD, when the last patient completed the last visit.
In SYN-ALD, we investigate the role of probiotics/synbiotics on 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.
The patients in SYN-ALD were randomized 1:1 to receive Profermin® versus Fresubin® for 6 months. The randomisation was 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.