A Pilot Study of Synbiotics in Adults With Depressive Symptoms

GenieBiome

Status

Enrolling

Conditions

Depressive Symptoms Mild to Moderate in Severity

Treatments

Dietary Supplement: MQU10

Study type

Interventional

Funder types

Industry

Identifiers

NCT06905223

AM01 (GB)

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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