A Pilot Study of Synbiotics in Adults With Depressive Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenieBiome Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
MQU10
Dietary supplementMQU10 consists of a blend of food-grade probiotic strains (20 billion CFU daily) and prebiotic compounds.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: MQU10Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
6 weeksSecondary outcomes
1
Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 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.
Time frame
6 weeks2
Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 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.
Time frame
6 weeks3
Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 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
Time frame
6 weeks4
Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 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
Time frame
6 weeksSponsors and contacts
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Source ClinicalTrials.gov