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Probiotic Visbiome for Adolescent Depression

This study is looking at whether a probiotic called Visbiome can help young people aged 15 to 24 who have depression. Visbiome is a mix of eight different good bacteria. You would either take Visbiome or a placebo (an inactive powder that looks the same) twice a day for eight weeks. Researchers will look at how the probiotic affects your brain's connections (specifically in the left hippocampus-precuneus area) and the types of bacteria in your gut. They will also check for any side effects. To join, you need to be 15-24 years old, speak English, have a smartphone or computer for remote visits, and have a diagnosed depressive disorder. The study aims to enroll 77 participants, but its current status is unclear.

Study design
This is a double-blind, placebo-controlled study, meaning neither you nor the study team will know if you're receiving Visbiome or the placebo. It plans to enroll 77 participants.
What's involved
You would take a powder mixed in water twice daily for eight weeks. You will have follow-up assessments every two weeks, either through Zoom video visits or in person.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at baseline and week 8, and side effects are assessed every two weeks from baseline to week 8.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06898788

Probiotic Administration for Adolescent Depression

Recruiting
EARLY_PHASE1Ages 15–24Interventional
University of California, San Francisco
~77 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:VisbiomePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Left hippocampus-precuneus resting state functional connectivity
Measured over Baseline and week 8
+2 more outcomes measured

Conditions

Depression

Explore related trials

Depression

NCT06898788

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UCSF

    San Francisco, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Cherry Leung, PhD, RN · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Cherry Leung, PhD, RN
[email protected]
(415) 502-0955
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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 medically-treated with stimulant medication for ADHD unless subject is on stable dosage of stimulant medication and there are no plans to change the stimulant medication or dosage for at least 8 weeks.
Current diagnosis of any Axis II personality disorder(s) as assessed by the K-SADS-COMP or SCID-V.
Oral probiotic use 1 month prior to phone screening
Oral or IV antibiotic use 1 month prior to phone screening
Fermented foods (e.g., yogurt, kombucha) 1 month prior to phone screening
Oral antioxidant or omega 3 supplements \<6 weeks prior to phone screening
Current alcohol intake greater than 2 drinks per week
Smoking cigarettes (\>5 during last 6 months) or tobacco (pipe or hookah #1 time during last month)
Any plans to make significant change in diet and lifestyle
Immunocompromised patients
Allergies to milk, soy, or yeast
Tanner Stage \<3
Current active suicidal ideation that requires psychiatric hospitalization or suicidal ideation with plan or intent to attempt suicide as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Prior suicide attempt within past 6 months that required hospitalization and/or visit to the Emergency Department
History of failure to clinically respond to 2 or more adequate trials of 2 different first-line SSRI antidepressant medications
Any contraindication to MRI (e.g., braces)
Pregnancy or any plans to become pregnant during the study is an exclusion criterion for entrance into the study. Women of reproductive capability will be asked about pregnancy or plans to become pregnant. Women of reproductive capability will be asked to employ at least one of the following allowable contraception methods until they complete their second MRI: birth control implant, birth control shot, birth control patch, birth control pill, condom, internal condom, birth control sponge, cervical cap, spermicide, fertility awareness (calendar method), outercourse and abstinence.

What this trial measures

  • Left hippocampus-precuneus resting state functional connectivityBaseline and week 8

    Measured with fMRI.

  • Beta diversityBaseline and week 8

    Gut microbiome measurement

  • Generic Assessment of Side Effects - Probiotics (GASE-P)Every 2 weeks from baseline to week 8

    Assesses for tolerability, safety, and adverse events.