NCT06898788 · University of California, San Francisco
Probiotic Administration for Adolescent Depression
(PAD)
What this study is about
This where neither patients nor doctors know which treatment is given, compared against an inactive treatment clinical trial will examine the effect of probiotic Visbiome on the brain and gut microbiome of individuals 15 to 24 years of age.
View original scientific 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.
Interventions
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.
DRUG
Placebo
Participants will be instructed to consume the powder mixed in water (same instructions as the probiotic group).
Primary outcome measures
Left hippocampus-precuneus resting state functional connectivity
Time frame: Baseline and week 8
Measured with fMRI.
Beta diversity
Time frame: Baseline and week 8
Gut microbiome measurement
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- San Francisco, California
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 6, 2025 · Source of record for eligibility and locations