Probiotic Administration for Adolescent Depression

NCT06898788 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: 24-41760R61AT012028
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Left hippocampus-precuneus resting state functional connectivity

  Measured with fMRI.

  Baseline and week 8

• Beta diversity

  Gut microbiome measurement

  Baseline and week 8

• Generic Assessment of Side Effects - Probiotics (GASE-P)

  Assesses for tolerability, safety, and adverse events.

  Every 2 weeks from baseline to week 8

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Visbiome 450 billion CFU (sachet) twice daily

Drug: Visbiome

Placebo twice daily

PLACEBO COMPARATOR

Placebo (maltose sachet) twice daily

Drug: Placebo

Interventions

Visbiome DRUG

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.

Probiotic

Placebo DRUG

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

Placebo twice daily

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94158, United States

RECRUITING

Related Publications (2)

• Ouwehand AC, Invernici MM, Furlaneto FAC, Messora MR. Effectiveness of Multistrain Versus Single-strain Probiotics: Current Status and Recommendations for the Future. J Clin Gastroenterol. 2018 Nov/Dec;52 Suppl 1, Proceedings from the 9th Probiotics, Prebiotics and New Foods, Nutraceuticals and Botanicals for Nutrition & Human and Microbiota Health Meeting, held in Rome, Italy from September 10 to 12, 2017:S35-S40. doi: 10.1097/MCG.0000000000001052.

  PMID: 29734210 BACKGROUND

• Liu RT, Walsh RFL, Sheehan AE. Prebiotics and probiotics for depression and anxiety: A systematic review and meta-analysis of controlled clinical trials. Neurosci Biobehav Rev. 2019 Jul;102:13-23. doi: 10.1016/j.neubiorev.2019.03.023. Epub 2019 Apr 17.

  PMID: 31004628 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Cherry Leung, PhD, RN

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherry Leung, PhD, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized into either the Visbiome® or placebo groups through computer-generated randomization at their initial baseline visit, with random block sizes ranging from 2 to 4 and stratification by sex.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized (1:1), 2-arm, single-center, placebo controlled

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 27, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)