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Gut feeling: can probiotics lift depression in metabolic syndrome?

NCT ID NCT06765057

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests whether a daily probiotic blend (called psychobiotics) can help ease depression and improve metabolic health in adults with pre-metabolic or metabolic syndrome. Sixty participants will take either the probiotic or a placebo for 12 weeks. Researchers will measure changes in depression, anxiety, waist size, blood sugar, blood pressure, and cholesterol.

What this could mean

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

Active substance
a multi-strain probiotic supplement (Ecologic® Barrier) containing 9 bacterial strains
What this could lead to
If it works, this could point toward a simple, safe add-on treatment for depression in people with metabolic problems.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply widely. The effect may be small or no better than 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 60 people

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

Started

Mar 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Major Depression Disorder (MDD) patients on antidepressants for at least 4 weeks or more. * MDD patients with pre-metabolic syndrome (at least 2 of the MetS components) and metabolic syndrome (at least 3 of the following components: central obesity with WC for men ≥ 94 centimeters while for women ≥ 80 centimeter, increased FPG ≥ 100 mg/dl, increased BP to ≥ 130 / ≥ 85 mmHg, increased TGs equal or above 150 mg / dl, increased HDL cholesterol for men to \< 40 mg / dl while for women \< 50 mg / dl) (IDF., 2006). * MDD patients with other comorbid diseases such as anxiety. Exclusion Criteria: * Patients using any other supplements to improve mood. * Patients using pre/pro/symbiotics supplement or antibiotics during the last 3 weeks before the intervention. * Patients with chronic diseases (cardiac, renal, or hepatic diseases) * Patients with gastro intestinal diseases (Crohn's disease, ulcerative colitis). * Patients with infectious diseases (HIV/AIDS). * Cancer patients or those undergoing chemotherapy. * Patients with food allergies such as gluten intolerance or lactose intolerance. * Pregnant and breastfeeding women. * Patients with modified antidepressant dose during interventional period or receiving psychotherapy during the intervention. * Patients with thyroid disorder. * Patients following a diet to lose weight during the intervention. * Diabetic patients who are insulin-dependent. * patients receiving injections or medications to lose weight (Ozempic, Mounjaro …etc) either 3 weeks before or during the intervention. * Patients using plasma-lipid lowering drug for less than 1 month before the intervention. * Patients with substance abuse including alcohol addiction.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • King Saud University Medical City

    RECRUITING

    Riyadh, Riyadh Region, Saudi Arabia

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