RECRUITING

Probiotic Administration for Adolescent Depression

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Probiotic Administration for Adolescent Depression

Quick Facts

Study Start:2025-02-17

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06898788

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.

Ages Eligible for Study:15 Years to 24 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Cherry Leung, PhD, RN

CONTACT

(415) 502-0955

cherry.leung@ucsf.edu

Principal Investigator

Cherry Leung, PhD, RN

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

UCSF

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

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 Registration Dates

Study Start Date2025-02-17

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-02-17

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Depression