Clinical trial NCT06905223: A Pilot Study of Synbiotics in Adults With Depressive Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms Mild to Moderate in Severity
Keywords: Depressive symptoms
Synbiotics
Adult Mood
Lead sponsor: GenieBiome Limited
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive one sachet of MQU10 for 6 weeks
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportions of subjects with improvement in condition, assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 6 weeks
timeFrame: 6 weeks
measure: Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 6 weeks
timeFrame: 6 weeks
measure: Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 6 weeks
timeFrame: 6 weeks
measure: Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 6 weeks
timeFrame: 6 weeks
measure: Changes in gut microbiota composition and functions by 6 weeks
timeFrame: 6 weeks
measure: Adverse events by 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: GenieBiome Limited
city: Hong Kong
country: Hong Kong
facility: Healthymind Centre
Study officials:
affiliation: GenieBiome Limited
name: Jessica Ching, PhD
role: STUDY_DIRECTOR
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