Novel study evaluates the microbiota-gut-brain axis as a pathway to supportive care in mental health challenges

ROCKVILLE, Md., June 7, 2022 /PRNewswire/ -- A new study published in the peer-reviewed journal Translational Psychiatry finds the Visbiome^® high-potency probiotic (containing the De Simone Formulation) may lessen symptoms of depression in patients with depressive disorder. The concept of using probiotics in depressive disorders has been the subject of growing interest in recent years as scientists have learned more about the linkage of the gut microbiome and certain neurobiological pathways, also known as the "microbiome-gut-brain axis." No one knows for sure how gut bacteria can influence behavioral health, but human and animal studies suggest the microbiome may be influencing certain neurobiological processes. Previous studies in humans have established certain benefits in psychiatric outcomes but many of the studies were limited to small sample sizes and certain design limitations. This new study provides some of the most robust clinical outcomes with a probiotic in depressive symptoms to date.

The study was conducted at the University Psychiatric Clinics Basel in Switzerland and enrolled patients with current depressive episodes. Patients were recruited to the study and evaluated based on a clinical depression rating scale called the Hamilton Rating Scale for Depression (HAM-D). The probiotic used in the study is an 8-strain blend of bacteria administered in an extremely high dose of 900 billion live bacteria per dose (sold as Visbiome in the US and Vivomixx in Europe.) In addition to customary treatments for depression, patients in the study consumed either the probiotic or a matched placebo.

The study results demonstrated that, over time, patients on the active probiotic exhibited decreased depressive symptom outcomes relative to the placebo (when patients complied with the treatment). Brain imaging showed that neural activity in the putamen, a region involved in emotional processing and associated with depression, decreased after probiotic supplementation. Moreover, the gut microbiome in the treated patients was also found to contain more friendly Lactobacillus species, which was associated with decreased depressive symptoms.

"These results are very encouraging as we seek to understand the impact of probiotics in the field of mental health," said Dr. André Schmidt, of the University of Basel and senior author of the study. "The crucial next step is to validate our findings in large-scale clinical studies and to identify biomarkers for stratified treatment guidance." 

Based in part on these results from Europe, the University of California San Francisco (UCSF) is planning a pilot clinical trial with the same probiotic agent in adolescents with clinical depression. That pilot trial is expected to start later this year.   

About ExeGi Pharma
ExeGi Pharma LLC is a biotechnology company focused on the development and commercialization of live biotherapeutic and probiotic medicines. ExeGi's team leverages scientific expertise in the field of microbiome science to deliver novel, clinically supported live biotherapeutic and probiotic products for a variety of unmet health and medical needs. ExeGi is headquartered in Rockville, MD.

About Visbiome
Visbiome (De Simone Formulation) is available in the U.S. as a medical food for the dietary management of dysbiosis associated with IBS, ulcerative colitis (UC), pouchitis, and hepatic encephalopathy (HE). Visbiome contains live, lyophilized, probiotic cultures for oral administration in doses of 112.5 billion to 900 billion live bacteria. The De Simone Formulation is sold under the name Vivomixx^® in Europe. 

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SOURCE ExeGi Pharma