A Pilot Study of Synbiotics in Adults With Depressive Symptoms

June 4, 2025 updated by: GenieBiome Limited

A Pilot Study on the Efficacy of a Synbiotic Formula (MQU10) in Improving Mood and Well-being in Adults With Mild to Moderate Depressive Symptoms

This study aims to explore the efficacy and safety of a synbiotic formula (MQU10) in improving mood and well-being in adults with mild to moderate depressive symptoms.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Major depression disorder (MDD) affects up to 20% of the population. In Hong Kong, one in seven suffered from mental health disorders with depressive disorder being one of the most frequent diagnoses. Depression is characterized by persistently low mood and loss of interest, possibly resulting from multifactorial factors including brain chemical abnormalities, genetics, stress, trauma and medical conditions. Current treatments for depression mainly include medication that alters neurotransmission in the brain and cognitive behavioural therapy to change cognitive distortions and their associated behaviours. However, there are side effects associated with the use of antidepressant medications as well as perceived stigma in receiving antidepressants and the uptake and accessibility of psychotherapy is extremely low. Thus, alternative therapeutic options are therefore needed to manage depression and its associated symptoms.

Emerging evidence suggests the important role of gut microbiota and gut-brain axis in mood regulation. In particular, there is high comorbidity among individuals with depression and gastrointestinal conditions such as irritable bowel syndrome and inflammatory bowel disease. There is also evidence suggesting that gut microbiota could produce metabolites and compounds with neuroactive and immunomodulatory properties. Previous studies have also supported the association between the dysbiosis of gut microbiota and affective disorders. Clinical trials on the use of microbiome-based therapeutics showed some efficacy in improving depression and insomnia. Gut microbiota modulation could be a novel therapeutic strategy for improving mood problems.

This pilot, single-arm study aims to explore the efficacy and safety of a synbiotic formula (MQU10), which is composed of food-grade probiotic strains and prebiotic compounds, in improving mood and well-being in adults with mild to moderate depressive symptoms.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • GenieBiome Limited
        • Contact:
        • Principal Investigator:
          • Ching-Ping Dennis CHEUNG
      • Hong Kong, Hong Kong

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged 18 or above
  • Patient Health Questionnaire-9 (PHQ-9) score between 5 to 14
  • Literate and can complete the self-report questionnaires
  • Able to understand the consent and sign the informed consent form

Exclusion Criteria:

  • Current diagnosis of substance abuse or dependence;
  • A current or past history of bipolar disorder, manic or hypomanic episodes, schizophrenia, personality disorder, posttraumatic stress disorder (PTSD), intellectual disability, neurodegenerative disorders (e. g, Parkinson's disease) or organic mental disorder
  • Requiring immediate psychiatric care (e. g, imminently suicidal subjects) or have attempted suicide in the past 3 months
  • Use of antipsychotics, antidepressants or sedatives, unless on a stable dose in the last 4 weeks
  • History of severe organ failure, renal failure on dialysis, HIV infection
  • Active malignancy within 5 years
  • History of major surgery on the gastrointestinal tract, except cholecystectomy and appendectomy in the past 5 years
  • Night shift work
  • History of antibiotic use within 4 weeks
  • History of allergy to probiotics or lactose leading to a severe allergic reaction
  • Known pregnancy or lactating

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MQU10
Subjects will take 1 sachet of synbiotics formula (MQU10) daily for 6 weeks
Dietary supplement: MQU10
MQU10 consists of a blend of food-grade probiotic strains (20 billion CFU daily) and prebiotic compounds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportions of subjects with improvement in condition, assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 6 weeks
Time Frame: 6 weeks
The improvement in condition will be assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 6 weeks. It is a 7-point Likert scale. The clinician investigator will rate the improvement as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 6 weeks
Time Frame: 6 weeks
The self-report improvement in condition will be assessed by Patient Global Impression of Change scale (PGI-C). It is a 7-point Likert scale. Subjects will rate their change as 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
6 weeks
Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 6 weeks
Time Frame: 6 weeks
Patient Health Questionnaire-9 (PHQ-9) is a 9-item instrument to assess the severity of depressive symptoms. Total score categories for PHQ-9 are 0-4 = minimal/no depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression.
6 weeks
Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 6 weeks
Time Frame: 6 weeks
Generalised Anxiety Disorder 7-item scale (GAD-7) consists of seven questions that measure the frequency and intensity of anxiety symptoms experienced over the past two weeks. The total score on the GAD-7 can range from 0 to 21, with higher scores indicating more severe anxiety symptoms
6 weeks
Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 6 weeks
Time Frame: 6 weeks
World Health Organization Quality of Life-BREF (WHOQOL-BREF) is a 26-item self-report instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health, with quality of life and general health items. Each item is scored on a five-point scale, and the scores are transformed linearly to a 0-100 scale
6 weeks
Changes in gut microbiota composition and functions by 6 weeks
Time Frame: 6 weeks
The changes of microbial profile in stool compared to baseline
6 weeks
Adverse events by 6 weeks
Time Frame: 6 weeks
The adverse events reported throughout the study
6 weeks

Collaborators and Investigators

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

Sponsor

GenieBiome Limited

Investigators

  • Study Director: Jessica Ching, PhD, GenieBiome Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 3, 2025

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

September 26, 2027

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM01 (GB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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