NCT06898788 Probiotic Administration for Adolescent Depression
| NCT ID | NCT06898788 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of California, San Francisco |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 77 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 77 participants in total. It began in 2025-05-15 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Cherry Leung, PhD, RN
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06898788 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 24 Years, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06898788 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06898788 currently recruiting?
Yes, NCT06898788 is actively recruiting participants. Contact the research team at cherry.leung@ucsf.edu for enrollment information.
Where is the NCT06898788 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06898788 clinical trial?
NCT06898788 is sponsored by University of California, San Francisco. The principal investigator is Cherry Leung, PhD, RN at University of California, San Francisco. The trial plans to enroll 77 participants.
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