Probiotics for Anxiety Depression: Evaluation of Clinical Efficacy and Safety

Study start date: March 1, 2026

Inclusion Criteria: * 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. Exclusion Criteria: * 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.