Efficacy and Safety of Probiotics for Anxiety Depression

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Anxiety Depression

In brief

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.

Key facts

Study ID

NCT07331987

Run by

Moon (Guangzhou) Biotechnology Co., Ltd.

People needed

60

Starts

2026-06-15

Expected to finish

2027-02-28

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1) Age: 18-60 years old; Gender: male or female.
• 2) Meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for a mild-to-moderate depressive or anxiety symptoms.
• 3) Hamilton Depression Rating Scale (HAM-D-24) score ≥ 8 or Hamilton Anxiety Rating Scale (HAM-A-14) score ≥ 7 at screening.
• 4) Has no used of anxiolytic or antidepressant medications (including traditional Chinese patent medicines), with the exception of Escitalopram Oxalate, within 2 weeks prior to the first dose.
• 5) For participants of childbearing potential (male or female): Must agree to use least one medically approve form of contraception (e.g., intrautering device [IUD], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative urine pregnancy test at screening and must be non-lactating.
• 6) The participant is willing and be able to provide written informed consent to participate in the study.

You may not qualify if…

• 1) HAM-D-24 score ≥ 35 or HAM-A-14 score ≥ 29.
• 2) Presence of significant suicidal ideation.
• 3) History or current diagnosis of neuropsychiatric disorders such as schizophrenia or epilepsy.
• 4) History of head trauma (with loss of consciousness for >10 minutes), other unstable major somatic diseases, or any somatic condition that could cause psychiatric symptoms.
• 5) Suspected intellectual disability.
• 6) History of alcohol or substance abuse prior to enrollment.
• 7) Cranial magnetic resonance imaging (MRI) reveals organic lesions.
• 8) Participants who are deemed unsuitable for the study by the investigator for any other reason.

Where it is running

• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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