A Pilot Study of Synbiotics in Adults With Depressive Symptoms

NCT06905223 | Recruiting

• 1 other identifier: AM01 (GB)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Depressive Symptoms Mild to Moderate in Severity

Keywords

Depressive symptoms; Synbiotics; Adult Mood

Outcome Measures

Primary Outcomes (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.

  6 weeks

Secondary Outcomes (6)

• Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 6 weeks

  6 weeks

• Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 6 weeks

  6 weeks

• Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 6 weeks

  6 weeks

• Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 6 weeks

  6 weeks

• Changes in gut microbiota composition and functions by 6 weeks

  6 weeks

Study Arms (1)

MQU10

EXPERIMENTAL

Subjects will take 1 sachet of synbiotics formula (MQU10) daily for 6 weeks

Dietary Supplement: MQU10

Interventions

MQU10 DIETARY_SUPPLEMENT

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

MQU10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenieBiome Limited: lead

Study Sites (2)

GenieBiome Limited

Hong Kong, Hong Kong

NOT YET RECRUITING

Healthymind Centre

Hong Kong, Hong Kong

RECRUITING

Related Publications (16)

• 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.

  PMID: 32009871 BACKGROUND

• 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.

  PMID: 34068669 BACKGROUND

• 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.

  PMID: 27509521 BACKGROUND

• 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.

  PMID: 38071990 BACKGROUND

• 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.

  PMID: 27632908 BACKGROUND

• 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.

  PMID: 39094854 BACKGROUND

• 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.

  PMID: 37023468 BACKGROUND

• 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.

  PMID: 30568608 BACKGROUND

• 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.

  PMID: 32668369 BACKGROUND

• 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.

  PMID: 35815493 BACKGROUND

• 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.

  PMID: 22968153 BACKGROUND

• 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.

  PMID: 29071061 BACKGROUND

• 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.

  PMID: 30455729 BACKGROUND

• 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.

  PMID: 23726508 BACKGROUND

• 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.

  PMID: 25660760 BACKGROUND

• Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.

  PMID: 15939839 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jessica Ching, PhD

  GenieBiome Limited

  STUDY DIRECTOR

Central Study Contacts

Emily Fung, BSc

CONTACT

(+852) 55024661; emilyfung@g-niib.com

Pui Kuan Cheong, MPH

CONTACT

(+852) 55024661; jcheong@g-niib.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive one sachet of MQU10 for 6 weeks

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: April 3, 2025
• Primary Completion: March 25, 2026
• Study Completion (Estimated): September 26, 2027
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)