Recruiting
Early Phase 1

Probiotic Administration

Sponsor:

UCLA

Code:

NCT06898788

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

Visbiome

Placebo

Study Details

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.

Conditions

Depression

Study ID

NCT06898788

Start date

May 15, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 24

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

77 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Probiotic

Visbiome 450 billion CFU (sachet) twice daily

placebo comparator: Placebo twice daily

Placebo (maltose sachet) twice daily

Interventions

Visbiome

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.

Placebo

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

Primary outcome measure

  • Left hippocampus-precuneus resting state functional connectivity [ Time Frame: Baseline and week 8 ]
  • Beta diversity [ Time Frame: Baseline and week 8 ]
  • Generic Assessment of Side Effects - Probiotics (GASE-P) [ Time Frame: Every 2 weeks from baseline to week 8 ]

Central Contacts and Locations

Central contacts

Cherry Leung, PhD, RN

(415) 502-0955cherry.leung@ucsf.edu

Locations

UCSF

Recruiting

San Francisco, California, United States, 94158

Contacts

Cherry Leung, PhD, RN

415-502-0955cherry.leung@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • probiotics
  • adolescents
  • gut microbiome
  • gut microbiota
  • fMRI
  • brain MRI
  • depression
  • depressive disorders
  • youth
  • young adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-07-14.