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

NCT06765057 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Depression Anxiety Disorder

Interventions

DIETARY_SUPPLEMENT

Winclove's Ecologic® Barrier Probiotics

The investigational product is a multispecies probiotic formulation consisting of 9 selected probiotic strains: the following bacterial strains: Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58.

DIETARY_SUPPLEMENT

Winclove's Ecologic® Barrier Probiotics Placebo

The placebo is composed of the carrier of the probiotic product that are identical in physical appearance, it includes maize starch and maltodextrins but contains no bacteria.

Sponsors & Collaborators

  • Roaa Ahmed Alkreadees

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-02
Primary Completion
2026-02-28
Completion
2027-01-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765057 on ClinicalTrials.gov