RecruitingEarly Phase 1NCT06898788

Probiotic Administration for Adolescent Depression


Sponsor

University of California, San Francisco

Enrollment

77 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 15 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a probiotic supplement — a product containing beneficial live bacteria — can help reduce symptoms of depression in young people aged 15 to 24 who are already taking an SSRI antidepressant but still experiencing significant depressive symptoms. Research suggests the gut-brain connection may play a role in mental health, and probiotics might enhance the effect of antidepressants. All study visits are conducted remotely via video call. **You may be eligible if...** - You are between 15 and 24 years old - You have been diagnosed with a depressive disorder (such as major depressive disorder or persistent depressive disorder) - You have been taking an SSRI antidepressant for at least 8 weeks - You still have significant depressive symptoms (BDI-II score above 13) - You are fluent in English and have access to a device with video calling capability - You are under the care of a doctor or mental health professional **You may NOT be eligible if...** - Your primary diagnosis is something other than a depressive disorder (e.g., schizophrenia, bipolar disorder) - You are currently not on an SSRI or have been on one for less than 8 weeks - You have unstable or unmanaged ADHD treated with stimulant medications - You do not have reliable internet access or a device for remote visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVisbiome

Visbiome® is an oral multi-strain probiotic which contains 8 strains: Lactobacillus (L.) paracasei, L. planatrum, L. acidophilus, L. helveticus, Bifidobacterium (B.) longum, B. infantis, B. breve, and Streptococcus (S.) thermophilus. Participants will be instructed to consume the powder mixed in water.

DRUGPlacebo

Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).


Locations(1)

UCSF

San Francisco, California, United States

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NCT06898788


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