Hanyang University
Seoul, 04763, South Korea
NCT Number: NCT06982599
This study was conducted to investigate effects of postbiotics on mood disorders in korean adults
This study is active but is not currently recruiting participants.
19 year–39 year
All sexes
Interventional
Not applicable
Seoul, 04763, South Korea
This study is an 8-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial. 52 participants were randomly assigned to either the postbiotics intervention group or a placebo group. The study aimed to evaluate the effects of postbiotics on mood disorders in Korean adults, comparing pre- and post-intervention mood profiles.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks
3 capsules/day placebo for 8 weeks
Time frame: week 0, week 8
Epidemiology Research Center Depression Scale (CES-D):
The Center for Epidemiologic Studies Depression Scale (CES-D) is a widely used 20-item self-reported instrument designed to measure depressive symptom severity in the general population. Each item is rated on a 4-point scale (0 to 3), assessing emotional, somatic, interpersonal, and positive affect domains over the past week. Total scores range from 0 to 60, with higher scores indicating more severe depressive symptoms.
Time frame: Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)
Ecological Momentary Assessment (EMA) captures real-time mood states by sending brief questionnaires to participants multiple times per day via online links. Each assessment includes six questions related to current mood and mental state, scored on a continuous slider scale from 0 (not at all) to 100 (very much). Higher scores indicate greater severity of negative mood or emotional distress. The average daily score will be calculated and used to assess change from baseline.
Time frame: week 0, week 8
The Depression Anxiety Stress Scale (DASS-21) is a validated self-report tool containing 21 items, divided equally into three subscales: depression, anxiety, and stress. Each item is rated on a 4-point scale (0 to 3), and subscale scores are summed. Each subscale score ranges from 0 to 21, with higher scores indicating more severe symptoms in the respective domain.
Time frame: Week 0, Week 8
The Perceived Stress Scale (PSS) is a validated 10-item self-report questionnaire assessing the degree to which situations in one's life are appraised as stressful. Each item is rated on a scale from 0 (never) to 4 (very often), with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress.
Time frame: Week 0, Week 8
Fecal samples will be collected for gut microbiota profiling using 16S rRNA gene sequencing. Participants will be asked to provide approximately 0.5 grams of stool in one container, collected within 24 hours prior to the clinic visit. The sample should be stored in a household freezer until delivery, and will be stored at -80°C upon arrival for microbial DNA extraction and analysis.
Time frame: Week 0, Week 8
For metabolite analysis using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), participants will be asked to provide approximately 0.5 grams of stool in each of two containers. These samples should be collected within 24 hours prior to the clinic visit, frozen at home, and delivered in a frozen state. Upon receipt, samples will be stored at -80°C for metabolomic profiling.
Time frame: Weekly from Week 0 to Week 8
The VAS-IBS is a self-report instrument that assesses gastrointestinal symptoms such as abdominal pain, bloating, diarrhea, constipation, and flatulence. Each symptom is rated on a visual analog scale from 0 (very severe) to 100 (very mild). Lower scores indicate more severe symptoms.
Hanyang University
Other
Effects of Postbiotics on Mood Disorders in Korean Adults: Eight Week, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00025935
Attention Deficit and Disruptive Behavior Disorders, Behavior
Bethesda, Maryland, United States
View Trial DetailsNCT00001177
Menstruation Disturbances, Mental Disorders
Bethesda, Maryland, United States
View Trial DetailsNCT00001231
Behavior, Behavioral Symptoms
Bethesda, Maryland, United States
View Trial DetailsNCT02721316
Adjustment Disorders, Mental Disorders
View Trial Details