ExeGi Pharma announced a new clinical trial testing its probiotic Visbiome in people with multiple sclerosis (MS). The study will further evaluate whether changing bacteria in the gut could be therapeutically beneficial in MS.

The human body hosts millions upon millions of bacterial guests, the majority of which live in the gut, comprising the gut microbiome. In recent decades, researchers have gained new appreciation for the important role these bacteria have in human health. Among other findings, studies have demonstrated these bacteria may play important roles in ensuring the proper function of the immune system.

MS is a disease characterized by a dysregulated immune system that attacks the body’s own cells; as such, there is a theoretical basis for targeting gut bacteria as a means to treat MS.

The study will be led by researchers at Columbia University Irving Medical Center in New York, and the University of Pittsburgh.

“The gut microbiome plays an important role in modulating the immune system, which is dysregulated in individuals with MS. This study will enhance our understanding about whether probiotics may be able to advantageously reshape the immune system and prevent degeneration of the nervous system,” Rebecca Farber, MD, professor at Columbia University, said in a press release.

Visbiome (marketed as Vivomixx in Europe) is a high-potency probiotic that contains eight strains of bacteria that are thought to be beneficial for regulating the immune system.

It was tested previously in a small study with nine MS patients and 13 healthy controls. The results suggested that Visbiome could change the composition of gut bacteria, decrease inflammation, and increase the effectiveness of existing therapies for MS.

The upcoming trial (NCT04038541), which is actively recruiting about 20 people, seeks to further explore these outcomes, with an eye toward understanding whether and how targeting the gut microbiome could benefit people with MS.

“We are excited about this opportunity to expand upon the available information on the effects of probiotics in multiple sclerosis patients,” Marc Tewey, CEO of ExeGi Pharma, said.

“The probiotic formulation in Visbiome has been the subject of over 70 human clinical studies, including a preliminary study in 2018 in MS patients,” Tewey said. “The findings of this new study will be beneficial for the scientific community as a whole by contributing important information about the complex relationship between the microbiome and immune system.”