The Austrian firm, which specialises in developing natural interventions from raw materials such as probiotics and plant extracts, has brought to market a multi-strain probiotic that has been clinically proven to improve the liver function of liver cirrhosis patients.
“At the moment the only possibilities in liver cirrhosis to improve liver function are to stop the causative factor, for example, alcohol, obesity or the hepatitis virus, or to perform a liver transplant. However stopping the causative factor doesn’t always lead to normalisation of liver function. Therefore a product that improves liver function is an unmet clinical need,” Mag. Anita Frauwallner, CEO and research director of Institut Allergosan, told NutraIngredients.
The multi-species product consists of Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58.
“Large meta-analyses have proven that multi-species probiotics are likely to be more effective than products with only one strain,” Frauwallner explained.
The product’s efficacy has been demonstrated in a placebo controlled, double blind study conducted by a team at the Medical University of Graz and published in Alimentary Pharmacology & Therapeutics.
101 patients with liver cirrhosis were given either the probiotic formulation or a placebo every day for six months. Two different scoring methods – Child-Pugh and MELD – were used to quantify liver function.
When looking at the Child-Pugh score, in the probiotic group, 38% of patients improved and 44% remained unchanged in terms of their liver function. In the placebo group 14% improved and 14% remained unchanged.
According to the MELD system, an improvement of one point was observed during the study period in the probiotic group whereas patients in the placebo group did not improve.
The researchers concluded that “the liver function of those who took the probiotic improved significantly”.
The mechanism of action
Less is known about the mechanism by which the probiotic appears to improve liver function.
“We have looked into a lot of details but could not find a single common biomarker of liver function in our patients that explains the improvement in liver function. In other words, the parameters that improved were very individual. However, we found an improvement in several parameters of innate immunity and inflammation as well as in microbiome composition,” said Frauwallner.
She said these data were still under investigation and would be submitted for publication soon.
Institut Allergosan has launched the product in its domestic market, as well as Germany and Switzerland, and has designs on other markets.
“We have planned roll outs together with our local partners in Central Europe and Asia in the near future, and are looking for strong partners in other countries, such as the USA and Australia, to supply our probiotics world-wide soon,” said Frauwallner.
In Austria and Germany, the product’s legal status is a ‘food for special medical purposes’, to be used for the ‘dietary management of hepatic dysfunction’.
The CEO said it was difficult to confirm its legal status in other markets as national regulations for foods for medical purposes vary from country to country.
The main distribution channel for OMNi-BiOTiC HETOX is pharmacies. The company said doctors and healthcare professionals already recommend and prescribe the product and that in some clinics, it is administered to patients with liver disease.
“It is our goal to make OMNi-BiOTiC HETOX available in all clinics that specialise in liver disease.”