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Recruiting EARLY_Phase 1 NCT06898788

Probiotic Administration for Adolescent Depression

Trial Parameters

Condition Depression
Sponsor University of California, San Francisco
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 77
Sex ALL
Min Age 15 Years
Max Age 24 Years
Start Date 2025-05-15
Completion 2026-08
Interventions
VisbiomePlacebo

Brief Summary

This double-blind, placebo-controlled clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.

Eligibility Criteria

Inclusion Criteria: * Female and male participants 15 to 24 years of age * Fluency in English * Access to smartphone, tablet, or computer, on which program "Zoom" can be run for remote visits * Diagnosed with a primary DSM-5 clinical depressive disorder (Major Depressive Disorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder). The DSM-5 clinical depressive disorder will be confirmed by the Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Computerized Version (K-SADS-COMP)47 to participants \<18 years and the Structured Clinic Interview for DSM-5 (SCID-V) to participants ≥18 years. * Participants must be under the care of a primary care clinician and/or mental health professional * Currently on SSRI for at least 8 weeks * BDI-II score greater than 13 Exclusion Criteria: * Current diagnosis of other DSM-5 mental health disorders except for anxiety disorders and ADHD as long as depressive disorder is the primary diagnosis * Current medi

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