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Gut bacteria may lift mood in bipolar depression

NCT ID NCT05762887

Symptom relief Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether taking probiotics (good bacteria) can reduce depressive symptoms in people with bipolar disorder. 141 adults were randomly assigned to receive either probiotics or a placebo for 12 weeks. The goal was to see if probiotics could improve mood and reduce depression scores.

What this could mean

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

Active substance
probiotics
What this could lead to
If it works, this could point toward a simple, natural supplement to help manage depression in bipolar disorder.
What could go wrong
This is a small, early-stage study. Probiotics may not work for everyone, and the results may not apply to all people with bipolar disorder.

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

141 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2025

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

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: * BD type I or type II, according to the use of Mini Internacional Neuropsychiatric Interview (MINI) * Score on the Young Mania Rating Scale (YMRS) \< 8 * Score on the Montgomery-Asberg Depression Rating Scale (MADRS) \> 8 * Be receiving major guideline-approved treatments for bipolar depression for at least 4 weeks Exclusion Criteria: * Pregnant or lactating women * Substance or alcohol dependence * Patients on prolonged antibiotic therapy, immunosuppressive therapies * A recent introduction of antidepressants in the last 15 days * Use of another probiotic, either in the form of food, sachets, capsules and others

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

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

Bipolar disorder

Contacts and locations

Locations

  • University of Sao Paulo

    São Paulo, São Paulo, 05403010, Brazil

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