Depressive Symptoms Mild to Moderate in Severity
Conditions
Keywords
Depressive symptoms, Synbiotics, Adult Mood
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.
Interventions
DIETARY_SUPPLEMENTMQU10
MQU10 consists of a blend of food-grade probiotic strains (20 billion CFU daily) and prebiotic compounds.
Sponsors
GenieBiome Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All subjects will receive one sachet of MQU10 for 6 weeks
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of subjects with improvement in condition, assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 6 weeks | 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. |
| Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 6 weeks | 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. |
| Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 6 weeks | 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 |
| Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 6 weeks | 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 |
| Changes in gut microbiota composition and functions by 6 weeks | 6 weeks | The changes of microbial profile in stool compared to baseline |
| Adverse events by 6 weeks | 6 weeks | The adverse events reported throughout the study |
Countries
Hong Kong
Contacts
STUDY_DIRECTORJessica Ching, PhD
GenieBiome Limited
Outcome results
None listed