Efficacy and Safety of Probiotics for Anxiety Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo + Escitalopram

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants receive Placebo once daily by oral for 3 months.

Escitalopram

Intervention Type COMBINATION_PRODUCT

Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Probiotics + Escitalopram

Group Type EXPERIMENTAL

Probiotic

Intervention Type DRUG

Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.

Escitalopram

Intervention Type COMBINATION_PRODUCT

Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Interventions

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Probiotic

Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.

Intervention Type DRUG

Placebo

Participants receive Placebo once daily by oral for 3 months.

Intervention Type DRUG

Escitalopram

Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No