Clinical trial NCT06982599: Effects of Postbiotics on Mood Disorders in Korean Adults
Official title: Effects of Postbiotics on Mood Disorders in Korean Adults: Eight Week, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mood Disorder
Keywords: mood disorder
postbiotics
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: DSM-Firmenich AG
First posted: 2025-05-21
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate effects of postbiotics on mood disorders in korean adults

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged between 19 and 39 years at the time of screening.
* BMI between 18.5 and 30 at the time of screening.
* CES-D (Center for Epidemiologic Studies Depression Scale) score of 16 or higher.
* Ability to access and respond to the survey via an online link.

Exclusion Criteria:

* Participation in any human clinical trial within the past 3 months before screening.
* History of antipsychotic medication treatment within the past 3 months before screening.
* Presence of chronic diseases, including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urological, neurological, musculoskeletal, inflammatory, hematological, oncological, or gastrointestinal disorders.
* Use of medications or health supplements related to gut health and mood disorders (e.g., antibiotics, laxatives, antidiarrheals, prebiotics, probiotics, postbiotics, anxiolytics, antidepressants, etc.) within 1 month prior to participation in the study.
* History of significant hypersensitivity to postbiotics or starch.
* Alcohol addiction, drug abuse, or suspicion of substance misuse.
* Pregnant or breastfeeding women.
* Any other reasons that the study investigator deems the participant unsuitable for participation.

Primary outcomes:
measure: Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo
timeFrame: week 0, week 8
measure: Effect of postbiotics on momentary mood measured by Ecological Momentary Assessment (EMA), compared with placebo
timeFrame: Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)
measure: Effect of postbiotics on psychological distress measured by the Depression Anxiety Stress Scale-21 (DASS-21), compared with placebo
timeFrame: week 0, week 8
Secondary outcomes:
measure: Effect of postbiotics on perceived stress measured by the Perceived Stress Scale (PSS), compared with placebo
timeFrame: Week 0, Week 8
measure: Effect of postbiotics on fecal microbiome composition, compared with placebo
timeFrame: Week 0, Week 8
measure: Effect of postbiotics on fecal metabolites, compared with placebo
timeFrame: Week 0, Week 8
measure: Effect of postbiotics on gastrointestinal symptoms measured by the Irritable Bowel Syndrome Visual Analog Scale (VAS-IBS), compared with placebo
timeFrame: Weekly from Week 0 to Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
References: