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Gut bacteria may soothe anxiety: new trial tests probiotics

NCT ID NCT07331987

Disease control Sponsor: Moon (Guangzhou) 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This study tests whether taking probiotics daily for 3 months can reduce symptoms of anxiety and depression in 60 adults with mild-to-moderate conditions. Participants will receive either probiotics, a placebo, or the antidepressant escitalopram. Researchers will measure changes in mood, sleep, and gut bacteria to see if probiotics offer a safe, natural way to support mental health.

What this could mean

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

Active substance
Probiotics (beneficial bacteria) and escitalopram (an antidepressant)
What this could lead to
If it works, this could point toward a simple, natural supplement to help manage mild-to-moderate anxiety and depression alongside standard care.
What could go wrong
This is a small, early-stage trial with only 60 people. Probiotics may not outperform placebo, and results may not apply to everyone with anxiety depression.

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 60 people

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

Started

Jun 2026

Expected to finish

Feb 2027

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 60 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: * 1\) Age: 18-60 years old; Gender: male or female. * 2\) Meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for a mild-to-moderate depressive or anxiety symptoms. * 3\) Hamilton Depression Rating Scale (HAM-D-24) score ≥ 8 or Hamilton Anxiety Rating Scale (HAM-A-14) score ≥ 7 at screening. * 4\) Has no used of anxiolytic or antidepressant medications (including traditional Chinese patent medicines), with the exception of Escitalopram Oxalate, within 2 weeks prior to the first dose. * 5\) For participants of childbearing potential (male or female): Must agree to use least one medically approve form of contraception (e.g., intrautering device \[IUD\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative urine pregnancy test at screening and must be non-lactating. * 6\) The participant is willing and be able to provide written informed consent to participate in the study. Exclusion Criteria: * 1\) HAM-D-24 score ≥ 35 or HAM-A-14 score ≥ 29. * 2\) Presence of significant suicidal ideation. * 3\) History or current diagnosis of neuropsychiatric disorders such as schizophrenia or epilepsy. * 4\) History of head trauma (with loss of consciousness for \>10 minutes), other unstable major somatic diseases, or any somatic condition that could cause psychiatric symptoms. * 5\) Suspected intellectual disability. * 6\) History of alcohol or substance abuse prior to enrollment. * 7\) Cranial magnetic resonance imaging (MRI) reveals organic lesions. * 8\) Participants who are deemed unsuitable for the study by the investigator for any other reason.

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression mixed anxiety and depressive disorder

As listed by the trial registrant

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

Anxiety depression

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 First Affiliated Hospital of Guangdong Pharmaceutical University

    RECRUITING

    Guangzhou, Guangdong, China

More trials for these conditions

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