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Gut health for mental health? probiotics join antidepressant in teen trial

NCT ID NCT07645157

Symptom relief Sponsor: First Affiliated Hospital of Chongqing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding multi-strain probiotics to the antidepressant sertraline helps teenagers aged 12-18 with major depression feel better than sertraline alone. Over 8 weeks, 120 participants will take either the combination or sertraline with a placebo. Researchers will track changes in depression scores and safety.

What this could mean

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

Active substance
sertraline and multi-strain probiotics
What this could lead to
If it works, this could point toward a simple, safe add-on treatment to better manage depression in teenagers.
What could go wrong
This is a small, early-phase trial (120 participants) testing a combination therapy, so results may not apply broadly. Probiotics may not provide additional benefit over placebo.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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

12 to 18 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: * • Aged 12-18 years * Meets DSM-5 criteria for major depressive disorder (MDD) and is currently in a depressive episode according to the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL) interviews * Child Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline * Clinical Global Impression Scale (CGI-S) score ≥ 4 at baseline Exclusion Criteria: * • Presence of any comorbid psychiatric disorder according to DSM-5, other than anxiety disorders * MDD with psychotic symptoms * Young Mania Rating Scale (YMRS) \>13 at baseline * History of neurological disorders (e.g., epilepsy, traumatic brain injury), or the presence of serious physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes mellitus, clinically significant pulmonary, hepatic, or renal impairment, or major trauma) * Nonresponse to at least two antidepressants with different mechanisms, and each administered at an adequate dose and for an adequate duration * History of intolerance to sertraline or nonresponse to an adequate therapeutic course of sertraline * Current high suicide risk * History of alcohol or drug abuse or dependence * Taking or administering antidepressants within 5 half-lives * Use of probiotic-related food or medicine within 2 weeks before enrollment * Systemic use of antibiotics or antifungals within 1 month before enrollment * History of severe food allergy or known hypersensitivity to the Lactobacillus crispatus preparation or any of its components * Adherence to vegetarian or other restrictive dietary patterns * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

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

Major depressive disorder (MDD) Probiotic intervention

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

  • The Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Yuzhong, 400010, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.