Gut feeling: could a probiotic ease depression in young brains?

NCT ID NCT06898788

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether a multi-strain probiotic called Visbiome can change brain activity and gut bacteria in people aged 15 to 24 with depression. Participants take either the probiotic or a placebo powder daily for several weeks. Researchers use brain scans and stool samples to see if the supplement affects mood-related brain circuits and the microbiome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an oral multi-strain probiotic called Visbiome
What this could lead to
If it works, this could point toward a new, side-effect-friendly way to help manage depression in young people by targeting the gut-brain connection.
What could go wrong
This is a very early, small study, so results may not be conclusive. Probiotics affect people differently, and any benefit might be modest or not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 77 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCSF

    RECRUITING

    San Francisco, California, 94158, United States

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