Efficacy and Safety of Probiotics for Anxiety Depression

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: Not yet recruiting
• Conditions: Anxiety Depression
• Intervention / Treatment: Drug: Placebo; Combination product: Escitalopram; Drug: Probiotic

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baojia Huang; Phone Number: +86-15588105007; Email: huangbj@moonbio.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangdong Pharmaceutical University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HAM-D-24)	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)	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

Outcome Measure	Measure Description	Time Frame
The Pittsburgh Sleep Quality Index (PSQI)	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)	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

• Sponsor: Moon (Guangzhou) Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 30, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Probiotics; Mood
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Amines; Nitriles; Propylamines; Benzofurans; Escitalopram; Probiotics
• Other Study ID 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