Probiotics to help depression and metabolic syndrome in adults
Effect of Probiotics "Psychobiotics" on Depression in Adults With Pre-Metabolic Syndrome and Metabolic Syndrome in Riyadh City
This trial will test whether taking a commercial multi‑strain 'psychobiotic' probiotic alongside antidepressants can ease depressive symptoms and improve weight and metabolic measures in adults with major depression and pre‑metabolic or metabolic syndrome.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | King Saud Medical City Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Riyadh, Riyadh Region) |
| Trial ID | NCT06765057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with major depressive disorder who are already taking antidepressants for at least four weeks and who meet criteria for pre‑metabolic syndrome or metabolic syndrome are ideal candidates.
Not a fit: People who are not on antidepressants, who do not have pre‑metabolic or metabolic syndrome, or who have excluded chronic or gastrointestinal diseases are unlikely to benefit from this specific intervention.
Why it matters
Potential benefit: If successful, the probiotic could offer a low‑risk add‑on that helps reduce depressive symptoms and improves metabolic health measures in this patient group.
How similar studies have performed: Previous small trials and pilot studies of psychobiotics have shown mixed but sometimes promising effects on mood and certain metabolic markers, while larger confirmatory trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Riyadh, Riyadh Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.