drugset / Trial / NCT07331987
Efficacy and Safety of Probiotics for Anxiety Depression
RandomizedParallel-groupTriple-blindTreatment
Summary
This randomized, double-blind, placebo-controlled study will enroll 60 individuals with mild-to-moderate anxiety depression. Following a 3-month intervention and a 1-month follow-up period, the study aims to: 1) evaluate the efficacy of probiotics by comparing anxiety, depression, and sleep scores to baseline; and 2) investigate the safety and underlying mechanisms by analyzing changes in serum biomarkers, gut microbiota, and related metabolites.
Timeline
- Start
- 2026-06-15
- Primary completion
- 2026-12-30
- Completion
- 2027-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VSL#3 | Other / unclassified | 6e+10 unknown | Oral |
| Background | Escitalopram | Small molecule | 10 mg | Oral |