“Key milestone”: Chr. Hansen trial finds probiotic potential for painkiller gut damage defense

16 May 2018 --- A Chr. Hansen clinical trial has demonstrated the effectiveness of probiotic strains in protecting against potential gut damage caused by the regular use of household painkillers. Chr. Hansen state that they will now focus on fully exploiting the strains full potential, deepening understanding of the underlying mechanisms and gathering sufficient data to publish in a scientific journal. The findings add to a growing research area using probiotics for health.

“This study further confirms the potential of probiotics in bringing benefits beyond well-studied areas in gastro-intestinal (GI) health and well-being. In that context, it is in line with our expectation that probiotics and beneficial bacteria from the microbiome will be of increasing relevance for the maintenance of health and the prevention and treatment of disease.” Johan van Hylckama Vlieg, Vice President of Microbiome & Human Health Innovation tells NutritionInsight.

“The clinical trial identified that participants taking the probiotic experienced a significant defense against GI damage caused by a widely used household painkiller compared to those who took the placebo. This indicates a clear protective effect from the strain – both regarding the reduction of intestinal damage and the number of ulcers caused.” 

The clinical trial used capsule endoscopy to reveal GI damage. It’s one of the first times that this advanced technology was used in a probiotic intervention trial.

Common GI side effects from household painkiller
The household painkiller is an NSAID (non-steroidal anti-inflammatory drugs), which are some of the most widely used pharmaceuticals in the world, according to Chr. Hansen. More than 50 million adults in the US take such drugs regularly. Chronic, low-dose use of the NSAID ASA is recommended for its cardiovascular-protecting properties and is today prescribed to 80 percent of those with an elevated cardiovascular risk profile in the US. 

However, Chr. Hansen adds that the regular use of NSAIDs can have side effects. ASA has emerged as one of the causes of ulcer bleeding in developed countries over the last two decades, underscoring an arguably unmet need to protect the gastrointestinal against damage caused by long-term and chronic NSAID therapy.

Probiotic innovation programme 
The clinical trial has been coined a “key milestone” in Chr. Hansen’s probiotic innovation program. One of the focus areas of the innovation program is to prove the potential of probiotic strains to protect against intestinal damage and develop these into proprietary products. 

“With this clinical data, we are breaking ground into a new field. As part of our Nature’s no.1 strategy, we work to unleash the potential of probiotics as a safe and effective solution into new health areas. To do this, we focus on careful strain selection, high-quality clinical trial design and professional execution”, explains van Hylckama Vlieg.

“Multiple paths for real-world implications can be envisioned, and today we are evaluating the different options. We are also currently performing additional scientific analyses in order to maximize the potential of our findings.” 

“However, we are still at the early scientific discovery stages and have not concluded on the final product concept yet,” he adds.

“With this particular strain, we have reached a key milestone. We are now continuing to invest in this concept to further investigate the potential of the strain. Our goal is to make it available to the many millions who need to take ASA regularly to support their long-term health,” concludes van Hylckama Vlieg.

The research builds on recent developments from Chr. Hansen regarding the use of probiotics strains in medical treatment. Last month, the company announced a partnership with Prota Therapeutics, developer of oral immunotherapies to treat food allergies. The partnership seeks to utilize Chr. Hansen’s probiotic strain, Lactobacillus rhamnosus (LGG) in the treatment of peanut allergies.

“Chr. Hansen has demonstrated the capability to deliver a pharmaceutical quality product that can be regulated as a biological therapeutic product. Together with our proprietary peanut protein formulation, we aim to progress this through to commercialization of a treatment for peanut allergies,” says Dr. Suzanne Lipe, CEO at Prota Therapeutics.

Regarding the medicines hitting the shelves, Thomas Gundelund Rasmussen, Director, Human Health and Microbiome Innovation told NutritionInsight at the time: “It will be approximately three years for the phase three clinical study, which is followed by discussions with the US FDA. After which, Prota intends to submit a Biologics License Application to FDA.”

By Laxmi Haigh