NCT07331987

Efficacy and Safety of Probiotics for Anxiety Depression

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Clinical Efficacy and Safety of Probiotics in Participants With Anxiety Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anxiety Depression

Interventions

Type	Name	Description
DRUG	Probiotic	Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.
DRUG	Placebo	Participants receive Placebo once daily by oral for 3 months.
COMBINATION_PRODUCT	Escitalopram	Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-30
• Completion: 2027-02-28
• First posted: 2026-01-12
• Last updated: 2026-01-15

Locations

1 site across 1 country: China