NCT06765057

Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia

Recruiting now Phase 2, PHASE3 Last updated 22 September 2025

What this trial tests

Phase 2, PHASE3 trial testing Winclove's Ecologic® Barrier Probiotics in Depression Anxiety Disorder in 60 participants. Currently enrolling.

Timeline

2 March 2025

Primary endpoint
28 February 2026

30 January 2027

Quick facts

Lead sponsor	Roaa Ahmed Alkreadees
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	2 March 2025
Primary completion	28 February 2026
Estimated completion	30 January 2027
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Winclove's Ecologic® Barrier Probiotics
• Winclove's Ecologic® Barrier Probiotics Placebo

Conditions studied

• Depression Anxiety Disorder — all drugs for Depression Anxiety Disorder →

Sponsor

Roaa Ahmed Alkreadees

Who can join

Adults 18 to 65, any sex, with Depression Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to assess the effect of commercial multi-strains psychobiotics supplementation as an ad-on therapy on depressive symptoms and metabolic syndrome components (HDL-C, FPG, TGs, WC, BP) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The second goal is to explore the effect of commercial multi-strains psychobiotics supplementation on the anthropometric measurement (weight, body mass index (BMI)) in adult depressed patients with pre-metabolic syndrome and metabolic syndrome. The main questions they aim to answer are:

* Will commercial multi-strains psychobiotics supplementation help to ease depressive symptoms as an ad-on therapy in patients with pre-metabolic syndrome and metabolic syndrome?
* Will commercial multi-strains psychobiotics supplementation improve anthropometric measurements and metabolic syndrome components (WC, FPG, BP, TGs, HDL-C) in depressed patients? Researchers will compare psychobiotics to a placebo (a look-alike substance that contains no drug) to see if psychobiotics work to improve depression and metabolic syndrome components.

Participants will:

* Be examined for depression, anxiety, and metabolic syndrome components (waist circumference, diabetes, blood pressure, triglycerides, and high-density lipoprotein).
* Be asked to conduct laboratory tests to determine the inclusion and exclusion criteria.
* Be given probiotics/ placebo to consume every day for 3 months (12 weeks).
* Repeat the examination and laboratory tests to determine the results.
* Be followed up weekly for adverse events and to insure their compliance with the study instructions.
* Be followed up after 4 weeks as an end-visit and will conduct the examination and the laboratory blood tests.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.