Probiotic Administration for Adolescent Depression (PAD)

June 4, 2025 updated by: University of California, San Francisco
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

77

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
Visbiome 450 billion CFU (sachet) twice daily
Drug: 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 Comparator: Placebo twice daily
Placebo (maltose sachet) twice daily
Drug: Placebo
Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left hippocampus-precuneus resting state functional connectivity
Time Frame: Baseline and week 8
Measured with fMRI.
Baseline and week 8
Beta diversity
Time Frame: Baseline and week 8
Gut microbiome measurement
Baseline and week 8
Generic Assessment of Side Effects - Probiotics (GASE-P)
Time Frame: Every 2 weeks from baseline to week 8
Assesses for tolerability, safety, and adverse events.
Every 2 weeks from baseline to week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Cherry Leung, PhD, RN, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-41760
  • R61AT012028 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results of this research will be made available via publication in scientific and medical journals as well as through scientific and medical meetings/conferences where our results will be reported. Publication of data will occur during the time course of this project consistent with normal scientific practices and consistent with NIH policies. Although the final dataset will be stripped of identifiers prior to release for sharing, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. The investigators will thus make the data and associated documentation available to users only under a data-sharing agreement that provides for the following: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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