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Gut bacteria may lift depression — a trial puts it to the test

NCT ID NCT07728253

Disease control Sponsor: IBIOME BIOTECHNOLOGY CO., LTD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This trial tests whether a probiotic called IBNI617 can reduce depression symptoms in adults with moderate to severe major depressive disorder. Participants take either the probiotic or a placebo capsule twice daily for 8 weeks. The study measures changes in depression scores and tracks any side effects.

What this could mean

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

Active substance
a live biotherapeutic product called IBNI617, taken as a capsule twice daily
What this could lead to
If it works, this could point toward a new gut-based treatment for depression that avoids standard antidepressant side effects.
What could go wrong
This is an early-phase trial with only 148 participants, so results may not apply broadly. The probiotic may not outperform placebo, and gut-related side effects are possible.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 148 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 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: * Meets DSM-5 criteria for a single episode or recurrent episode; * HAM-D-17 ≥ 22, total score of HAM-D-17 items 4, 5, and 6 ≥ 3; * MADRS ≥ 20, CGI-S ≥ 4; * Absence of antidepressant medication use or discontinuation of antidepressant medication prior to screening. Exclusion Criteria: * Treatment-resistant depression; * Suicide attempt or suicide behavior within the past 6 months; * Used antibiotics within the past 2 weeks; * Currently use insomnia medication, excluding non-benzodiazepine drugs taken consistently for 4 weeks; * With medical history or surgical history that may affect probiotic colonization.

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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.

IBNI617 Major depressive disorder (MDD)

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

  • Shanghai Mental Health Center

    Shanghai, China

More trials for these conditions

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