Holobiome and Radicle Science Launch Largest U.S. Mental Wellness Trial Targeting Gut-Brain Axis

Holobiome launches the trial with partner Radicle Science, describing it as the largest mental wellness study in U.S. history, focusing on the gut‑brain connection. It aims to enroll a broad participant pool across multiple sites.

Radicle Science will provide its proprietary microbiome analysis platform to measure participants’ gut bacteria, linking changes to mental health questionnaires administered throughout the study. The company says the data could reveal new pathways for treatment.

The trial includes regular follow‑up visits where participants provide stool samples and complete standardized mood assessments, allowing researchers to track how dietary interventions influence psychological scores over time. Results are planned for public release after the final analysis.

Researchers hope the study will inform future digital wellness standards and guide policy makers, including WHO and FDA, as they develop guidelines for gut‑brain based mental health interventions. Success could shift clinical practice toward microbiome‑focused care.