Efficacy and Safety of Probiotics for Anxiety Depression

June 25, 2026 updated by: Moon (Guangzhou) Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
          • IRB, First Affiliated Hosp, Guangdong Pharm Univ
          • Phone Number: 86-020-87609616
          • Email: gylunli@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo + Escitalopram
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.
Experimental: Probiotics + Escitalopram
Combination product: Escitalopram
Participants receive Escitalopram Oxalate Tablets once daily by oral, 10mg/day for 3 months.
Drug: Probiotic
Participants receive Probiotic product once daily by oral, 60B CFU/day for 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HAM-D-24)
Time Frame: Baseline, Day 30, Day 90, Day 120 (follow up)
Depression symptoms will be assessed using the 24-item Hamilton Depression Rating Scale (HAM-D-24) at baseline and the specified time points during the study. With higher scores indicating more severe depression, and scores categorized as <8 non-depressed, 8-19 mild, 20-34 moderate, ≥35 severe for diagnosis and monitoring treatment response.
Baseline, Day 30, Day 90, Day 120 (follow up)
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Baseline, Day 30, Day 90, Day 120 (follow up)
Anxiety symptoms will be evaluated using 14-item Hamilton Anxiety Rating Scales (HAM-A) at baseline and the specified time point during the study. Each item is scored on a scale of 0 (not present) to 4 (severe). The total score, calculated by summing all items, ranges from 0 to 56, with higher scores indicating greater anxiety severity, where 0-7 indicates no/minimal, 8-14 mild, 15-23 moderate and ≥24 severe.
Baseline, Day 30, Day 90, Day 120 (follow up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, Day 30, Day 90, Day 120 (follow up)
Assesses sleep quality from baseline to end of the study by questionnaire of The Pittsburgh Sleep Quality Index (PSQI). There are 19 items that are used to generate 7 component scores, which then are added together to determine a global score that ranges between 0 to 21, where higher scores reflect worse sleep quality.
Baseline, Day 30, Day 90, Day 120 (follow up)
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, Day 30, Day 90, Day 120 (follow up)
Assessment of gastrointestinal symptoms will conducted at baseline and throughout the study period. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Baseline, Day 30, Day 90, Day 120 (follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Moon (Guangzhou) Biotechnology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MN-MOOD-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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