Gut feeling: can probiotics lift depression in metabolic syndrome?
NCT ID NCT06765057
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Depression anxiety disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGRiyadh, Riyadh Region, Saudi Arabia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new oral drug lift severe depression?
- Magnetic pulses target teen depression
- Which exercise dose best helps kids with metabolic syndrome?
- Can an antipsychotic restore feelings in people with depression?
- Can intense brain zaps lift depression? scientists track blood flow in real time
- Can a weekly weight drug quiet gout attacks?