A Phase 2, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients with Major Depression
Evidence has shown considerable individual variability in bacterial content of the gut microbiota, which is hypothesized to influence brain function. Research examining this relationship suggests that microbiota transplantation may aid in improving depression symptoms by recolonizing the gastrointestinal tract with healthy bacteria. The study will examine the effects of a microbial therapeutic composed of various strains of gut bacteria from a healthy donor on mood. Treatment-naïve adults diagnosed with major depression will orally consume once daily either an encapsulated microbial therapeutic, containing various strains of bacteria purified and lab-grown from a single healthy donor stool or a placebo, for 6 weeks. We expect to observe an improvement in depressive symptoms following treatment, and that this improvement will be mediated GI tract recolonization with healthy bacteria. The findings of this study may be the first to provide evidence for the role of microbial therapy in alleviating symptoms of depression.