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Depressive Symptoms Mild to Moderate in SeverityNCT06905223

A Pilot Study of Synbiotics in Adults With Depressive Symptoms

A study testing MQU10 in people with Depressive Symptoms Mild to Moderate in Severity, run by GenieBiome Limited at 2 sites in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MQU10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesHong Kong
Study dates
3 Apr 2025to 26 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites
  • GenieBiome Limited

    Hong Kong

  • Healthymind Centre

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read the 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.

Being tested
MQU10
Keywords
Depressive symptoms, Synbiotics, Adult Mood
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MQU10Dietary supplement

    MQU10 consists of a blend of food-grade probiotic strains (20 billion CFU daily) and prebiotic compounds.

Study groups in NCT06905223
Study groupRoleWhat they receive
MQU10ExperimentalSubjects will take 1 sachet of synbiotics formula (MQU10) daily for 6 weeks
Receives: Dietary Supplement: MQU10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportions of subjects with improvement in condition, assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 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.

    Measured: 6 weeks

Secondary outcomes (6)
  1. Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 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.

    Measured: 6 weeks

  2. Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 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.

    Measured: 6 weeks

  3. Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 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

    Measured: 6 weeks

  4. Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 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

    Measured: 6 weeks

  5. Changes in gut microbiota composition and functions by 6 weeks

    The changes of microbial profile in stool compared to baseline

    Measured: 6 weeks

  6. Adverse events by 6 weeks

    The adverse events reported throughout the study

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start3 Apr 2025
  3. Primary completion31 Aug 2025
  4. Study completion26 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects will receive one sachet of MQU10 for 6 weeks
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905223
Sponsor's protocol ID
AM01 (GB)
Status last verified
Sep 2026
First submitted
25 Mar 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yong SJ, Tong T, Chew J, Lim WL. Antidepressive Mechanisms of Probiotics and Their Therapeutic Potential. Front Neurosci. 2020 Jan 14;13:1361. doi: 10.3389/fnins.2019.01361. eCollection 2019.

    PubMed 32009871
  • Poluektova E, Yunes R, Danilenko V. The Putative Antidepressant Mechanisms of Probiotic Bacteria: Relevant Genes and Proteins. Nutrients. 2021 May 10;13(5):1591. doi: 10.3390/nu13051591.

    PubMed 34068669
  • Huang R, Wang K, Hu J. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Aug 6;8(8):483. doi: 10.3390/nu8080483.

    PubMed 27509521
  • Lau RI, Su Q, Lau ISF, Ching JYL, Wong MCS, Lau LHS, Tun HM, Mok CKP, Chau SWH, Tse YK, Cheung CP, Li MKT, Yeung GTY, Cheong PK, Chan FKL, Ng SC. A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2024 Mar;24(3):256-265. doi: 10.1016/S1473-3099(23)00685-0. Epub 2023 Dec 7.

    PubMed 38071990
  • Pirbaglou M, Katz J, de Souza RJ, Stearns JC, Motamed M, Ritvo P. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials. Nutr Res. 2016 Sep;36(9):889-898. doi: 10.1016/j.nutres.2016.06.009. Epub 2016 Jun 21.

    PubMed 27632908
  • Ito H, Tomura Y, Kitagawa Y, Nakashima T, Kobanawa S, Uki K, Oshida J, Kodama T, Fukui S, Kobayashi D. Effects of probiotics on sleep parameters: A systematic review and meta-analysis. Clin Nutr ESPEN. 2024 Oct;63:623-630. doi: 10.1016/j.clnesp.2024.07.006. Epub 2024 Aug 2.

    PubMed 39094854
  • Gil-Hernandez E, Ruiz-Gonzalez C, Rodriguez-Arrastia M, Ropero-Padilla C, Rueda-Ruzafa L, Sanchez-Labraca N, Roman P. Effect of gut microbiota modulation on sleep: a systematic review and meta-analysis of clinical trials. Nutr Rev. 2023 Nov 10;81(12):1556-1570. doi: 10.1093/nutrit/nuad027.

    PubMed 37023468
  • Li Y, Hao Y, Fan F, Zhang B. The Role of Microbiome in Insomnia, Circadian Disturbance and Depression. Front Psychiatry. 2018 Dec 5;9:669. doi: 10.3389/fpsyt.2018.00669. eCollection 2018.

    PubMed 30568608
  • Matenchuk BA, Mandhane PJ, Kozyrskyj AL. Sleep, circadian rhythm, and gut microbiota. Sleep Med Rev. 2020 Oct;53:101340. doi: 10.1016/j.smrv.2020.101340. Epub 2020 May 13.

    PubMed 32668369
  • Haarhuis JE, Kardinaal A, Kortman GAM. Probiotics, prebiotics and postbiotics for better sleep quality: a narrative review. Benef Microbes. 2022 Aug 3;13(3):169-182. doi: 10.3920/BM2021.0122. Epub 2022 Jul 11.

    PubMed 35815493
  • Cryan JF, Dinan TG. Mind-altering microorganisms: the impact of the gut microbiota on brain and behaviour. Nat Rev Neurosci. 2012 Oct;13(10):701-12. doi: 10.1038/nrn3346. Epub 2012 Sep 12.

    PubMed 22968153
  • Clapp M, Aurora N, Herrera L, Bhatia M, Wilen E, Wakefield S. Gut microbiota's effect on mental health: The gut-brain axis. Clin Pract. 2017 Sep 15;7(4):987. doi: 10.4081/cp.2017.987. eCollection 2017 Sep 15. No abstract available.

    PubMed 29071061
  • Brown JSL. Increasing access to psychological treatments for adults by improving uptake and equity: rationale and lessons from the UK. Int J Ment Health Syst. 2018 Nov 9;12:67. doi: 10.1186/s13033-018-0246-7. eCollection 2018.

    PubMed 30455729
  • Bet PM, Hugtenburg JG, Penninx BW, Hoogendijk WJ. Side effects of antidepressants during long-term use in a naturalistic setting. Eur Neuropsychopharmacol. 2013 Nov;23(11):1443-51. doi: 10.1016/j.euroneuro.2013.05.001. Epub 2013 May 30.

    PubMed 23726508
  • Lam LC, Wong CS, Wang MJ, Chan WC, Chen EY, Ng RM, Hung SF, Cheung EF, Sham PC, Chiu HF, Lam M, Chang WC, Lee EH, Chiang TP, Lau JT, van Os J, Lewis G, Bebbington P. Prevalence, psychosocial correlates and service utilization of depressive and anxiety disorders in Hong Kong: the Hong Kong Mental Morbidity Survey (HKMMS). Soc Psychiatry Psychiatr Epidemiol. 2015 Sep;50(9):1379-88. doi: 10.1007/s00127-015-1014-5. Epub 2015 Feb 8.

    PubMed 25660760

Questions about this trial

What is this clinical trial studying?

A study testing MQU10 in people with Depressive Symptoms Mild to Moderate in Severity, run by GenieBiome Limited at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06905223, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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