Status:
RECRUITING
A Pilot Study of Synbiotics in Adults With Depressive Symptoms
Lead Sponsor:
GenieBiome Limited
Conditions:
Depressive Symptoms Mild to Moderate in Severity
Eligibility:
All Genders
18+ years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06905223
Start Date
April 3 2025
End Date
September 26 2027
Last Update
June 8 2025
Active Locations (2)
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1
GenieBiome Limited
Hong Kong, Hong Kong
2
Healthymind Centre
Hong Kong, Hong Kong