Probiotics to help depression and metabolic syndrome in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with major depressive disorder who have pre‑metabolic syndrome or metabolic syndrome and have been on antidepressants for at least four weeks are randomized to receive either a commercial multi‑strain psychobiotic supplement or a matching placebo as an add‑on therapy. Investigators will compare changes in depressive symptoms, metabolic syndrome components (waist circumference, fasting plasma glucose, blood pressure, triglycerides, HDL cholesterol), and anthropometric measures (weight, BMI) between the two groups. The intervention uses Winclove's Ecologic® Barrier Probiotics versus placebo and is conducted at a single center in Riyadh. Outcomes will be measured at baseline and after the intervention period to determine any clinical and metabolic effects of the supplement.

Why it matters

Who can join: the full rules

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.

Where it's running

• King Saud University Medical City
  Riyadh, Riyadh Region, Saudi Arabia Recruiting

Study contacts

• Study coordinator: Roaa A Alkreadees
• Email: 442203635@student.ksu.edu.sa
• Phone: 00966555527073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.