Probiotic Administration for Adolescent Depression

Last updated: June 4, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

1

Condition

Depression

Treatment

Placebo

Visbiome

Clinical Study ID

NCT06898788
24-41760
R61AT012028
  • Ages 15-24
  • All Genders

Study 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

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 forremote visits

  • Diagnosed with a primary DSM-5 clinical depressive disorder (Major DepressiveDisorder, Persistent Depressive Disorder, or Other Specified Depressive Disorder).The DSM-5 clinical depressive disorder will be confirmed by the Schedule forAffective Disorders and Schizophrenia for School-Aged Children-Computerized Version (K-SADS-COMP)47 to participants <18 years and the Structured Clinic Interview forDSM-5 (SCID-V) to participants ≥18 years.

  • Participants must be under the care of a primary care clinician and/or mental healthprofessional

  • Currently on SSRI for at least 8 weeks

  • BDI-II score greater than 13

Exclusion

Exclusion Criteria:

  • Current diagnosis of other DSM-5 mental health disorders except for anxietydisorders and ADHD as long as depressive disorder is the primary diagnosis

  • Current medically-treated with stimulant medication for ADHD unless subject is onstable dosage of stimulant medication and there are no plans to change the stimulantmedication or dosage for at least 8 weeks.

  • Current diagnosis of any Axis II personality disorder(s) as assessed by theK-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 timeduring 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 orsuicidal ideation with plan or intent to attempt suicide as assessed by theColumbia-Suicide Severity Rating Scale (C-SSRS)

  • Prior suicide attempt within past 6 months that required hospitalization and/orvisit to the Emergency Department

  • History of failure to clinically respond to 2 or more adequate trials of 2 differentfirst-line SSRI antidepressant medications

  • Any contraindication to MRI (e.g., braces)

  • Pregnancy or any plans to become pregnant during the study is an exclusion criterionfor entrance into the study. Women of reproductive capability will be asked aboutpregnancy or plans to become pregnant. Women of reproductive capability will beasked to employ at least one of the following allowable contraception methods untilthey complete their second MRI: birth control implant, birth control shot, birthcontrol patch, birth control pill, condom, internal condom, birth control sponge,cervical cap, spermicide, fertility awareness (calendar method), outercourse andabstinence.

Study Design

Total Participants: 77
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 15, 2025
Estimated Completion Date:
December 31, 2026

Study Description

This trial will evaluate the effects of Visbiome 450 billion CFU taken orally twice daily on the biological signature of left hippocampal (HP) resting-state functional connectivity (RSFC) and gut microbiome composition in individuals between the ages of 15 and 24 years.This study will assess the safety and tolerability of Visbiome at this dosage.

Participants will be enrolled in the study for a total of eight weeks and randomized to the probiotic or placebo group. Follow-up assessments will take place every two weeks and will be conducted either through Zoom video visits or in person. The primary outcomes of the study include the effects of the intervention on neural connectivity and gut microbiome composition. Neural connectivity will be assessed by measuring the left HP RSFC using functional magnetic resonance imaging (fMRI). Gut microbiome composition will be evaluated by assessing beta diversity through stool samples collected at baseline and post-intervention.

The safety and tolerability of the intervention will be carefully monitored throughout the study. Adverse events will be systematically collected at each visit, graded for severity, and evaluated for their relationship to the probiotic intervention. Tolerability will be assessed using the Generic Assessment of Side Effects - Probiotics (GASE-P). This measure will be administered at baseline and every two weeks throughout the study period.

Connect with a study center

  • UCSF

    San Francisco, California 94158
    United States

    Active - Recruiting

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