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Efficacy and Safety of Probiotics for Anxiety Depression

NCT07331987 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Moon (Guangzhou) Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-30
Completion
2027-02-28

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331987 on ClinicalTrials.gov