Effect of Probiotics "Psychobiotics" on Depression and Metabolic Syndrome in Saudi Arabia
Recruiting
Phase 2
Phase 3
Interventional Study
Depression Anxiety Disorder
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Roaa Ahmed Alkreadees · Government
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About This Trial
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 t…
Trial Locations
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Eligibility 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 centime…
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