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Gut bacteria as a mood booster? trial tests probiotic for depression

NCT ID NCT07776145

Symptom relief Sponsor: Cairo University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a daily probiotic supplement containing Lactobacillus plantarum can improve cognitive function and reduce depressive symptoms in women aged 50-64 with mild depression. Over 12 weeks, participants will take either the probiotic or a placebo capsule, and researchers will measure changes in memory, mood, inflammation, and heart rate variability. The goal is to see if supporting the gut-brain connection can offer a natural approach to mental well-being.

What this could mean

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

Active substance
a probiotic supplement containing Lactobacillus plantarum (10 billion CFU per capsule) taken daily for 12 weeks
What this could lead to
If it works, this could point toward a simple, drug-free way to ease mild depression and support brain health in older women.
What could go wrong
This is a small, early-stage trial, and the benefits may be modest or not appear at all. Probiotics are generally safe, but individual responses can vary.

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 88 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

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

50 to 64 years

Sex

Female participants only

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: Females, aged 50-64 years * Presence of mild depressive symptoms, defined as a Beck Depression inventory II (BDI-II) total score between 14 and 19 (inclusive) at the screening visit. * Ability to give informed consent Exclusion Criteria: * Moderate and severe depression (BDI-II score \> 19) or active suicidal ideation (assessed by clinical interview). * Diagnosis of bipolar disorder, schizophrenia, or other major psychotic disorder. Current use of antidepressants, antipsychotics, mood stabilizers, or regular anxiolytics * Regular consumption of probiotics, prebiotics, or synbiotic supplements within the past 4 weeks. * Use of antibiotics or antifungals within the past 4weeks. * Known diagnosis of inflammatory bowel disease, celiac disease, or active irritable bowel syndrome with severe symptoms. * History of significant cardiovascular disease (e.g., atrial fibrillation, heart failure, recent MI), uncontrolled hypertension, or type 1 diabetes. * Current use of systemic hormone replacement therapy within the last 3 months.Research Template 6 Final Version: Jan 2024 * Known allergy to any component of the probiotic or placebo. * Severe systemic illness (e.g., uncontrolled diabetes, malignancy, severe hepatic, renal disease or auto-immune diseases). * CRP more than 10

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Conditions

The condition(s) this trial relates to.

depressive disorder

As listed by the trial registrant

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

Cognition function Mild depression

How to take part

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  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

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Contacts and locations

Locations

  • Cairo University (Kasr Alainy teaching hospitals)

    Cairo, Egypt

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