Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06905223

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

Led by GenieBiome Limited · Updated on 2025-06-08

30

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore the effectiveness and safety of a synbiotic formula called MQU10 in improving mood and well-being among adults experiencing mild to moderate depressive symptoms. Depression affects many people worldwide and is linked to complex causes including brain chemistry, genetics, and stress. Traditional treatments like medication and therapy have limitations, so this study investigates a new approach targeting gut health's role in mood regulation. Participants will take one sachet of the synbiotic formula MQU10 daily for six weeks. MQU10 contains food-grade probiotic strains and prebiotic compounds designed to influence the gut microbiota, which may impact mood and mental health. This is a single-arm pilot study, meaning all subjects receive the synbiotic treatment without a comparison group. During the study, researchers will assess changes in participants' mood and well-being using various scales including the Clinical Global Impression - Global Improvement Scale at six weeks. Other evaluations include questionnaires on depression, anxiety, quality of life, and analysis of gut microbiota changes. Safety will be monitored by recording any adverse events. The total participation period is six weeks.

CONDITIONS

Brief Title

A Pilot Study of Synbiotics in Adults With Depressive Symptoms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 18 or above
  • Patient Health Questionnaire-9 (PHQ-9) score between 5 to 14
  • Literate and able to complete self-report questionnaires
  • Able to understand and sign the informed consent form
Not Eligible

You will not qualify if you...

  • Current diagnosis of substance abuse or dependence
  • History of bipolar disorder, manic or hypomanic episodes, schizophrenia, personality disorder, PTSD, intellectual disability, neurodegenerative disorders, or organic mental disorder
  • Requiring immediate psychiatric care or suicide attempt in past 3 months
  • Use of antipsychotics, antidepressants or sedatives unless on stable dose for 4 weeks
  • History of severe organ failure, renal failure on dialysis, or HIV infection
  • Active cancer within 5 years
  • Major gastrointestinal surgery except cholecystectomy or appendectomy in past 5 years
  • Night shift work
  • Antibiotic use within 4 weeks
  • Allergy to probiotics or lactose causing severe reaction
  • Known pregnancy or lactating

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants take one sachet of the synbiotic formula (MQU10) daily to explore its effects on mood and well-being.

Weekly visits for up to 6 weeks

Trial Site Locations

Total: 2 locations

1

GenieBiome Limited

Hong Kong, Hong Kong

Not Yet Recruiting

2

Healthymind Centre

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

E

Emily Fung, BSc

P

Pui Kuan Cheong, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Frequently Asked Questions

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Published Research Related To This Trial

A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial.

Raphaela I Lau, Qi Su, Ivan S F Lau...

https://pubmed.ncbi.nlm.nih.gov/38071990

Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials.

Meysam Pirbaglou, Joel Katz, Russell J de Souza...

https://pubmed.ncbi.nlm.nih.gov/27632908

Effect of gut microbiota modulation on sleep: a systematic review and meta-analysis of clinical trials.

Esther Gil-Hernández, Cristofer Ruiz-González, Miguel Rodriguez-Arrastia...

https://pubmed.ncbi.nlm.nih.gov/37023468