ClinicalTrials.gg
Active, not recruitingNCT06982599Updated Jan 12, 2026

Effects of Postbiotics on Mood Disorders in Korean Adults

An interventional study of postbiotics and placebo in Mood Disorder, sponsored by Hanyang University. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Hanyang University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
19 Years to 39 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Mood Disorder

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Keywords

  • mood disorder
  • postbiotics
03

In context

Mood Disorders

561 studies on the registry are indexed under Mood Disorders; 105 are open to participants now.

This study's planned enrollment of 52 is below the median of 80 across 419 interventional studies indexed under Mood Disorders.

Browse Mood Disorders studies →

Lead sponsor

Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged between 19 and 39 years at the time of screening.
  • 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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    postbiotics

    3 capsules/day postbiotics (20 × 10\^9 CFU/day) for 8 weeks

    Dietary Supplement: postbiotics

  • Placebo comparator
    Placebo

    3 capsules/day placebo for 8 weeks

    Dietary Supplement: placebo

Interventions

  • Dietary supplementpostbiotics

    3 capsules/day postbiotics (20 × 10\^9 CFU/day) for 8 weeks

  • Dietary supplementplacebo

    3 capsules/day placebo for 8 weeks

06

What researchers measure

Primary outcomes

  1. Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo

    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: week 0, week 8

  2. Effect of postbiotics on momentary mood measured by Ecological Momentary Assessment (EMA), compared with placebo

    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: Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)

  3. Effect of postbiotics on psychological distress measured by the Depression Anxiety Stress Scale-21 (DASS-21), compared with placebo

    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

Secondary outcomes

  1. Effect of postbiotics on perceived stress measured by the Perceived Stress Scale (PSS), compared with placebo

    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

  2. Effect of postbiotics on fecal microbiome composition, compared with placebo

    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

  3. Effect of postbiotics on fecal metabolites, compared with placebo

    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: Week 0, Week 8

  4. Effect of postbiotics on gastrointestinal symptoms measured by the Irritable Bowel Syndrome Visual Analog Scale (VAS-IBS), compared with placebo

    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.

    Time frame: Weekly from Week 0 to Week 8

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2025 to primary completion in Dec 2025, 2 months.

Of 151 non-industry interventional studies with no phase under Mood Disorders, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 2 months is below that.

Counting every sponsor, half of 162 studies reached it within 21 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2025
First posted
May 21, 2025
StartActual
Oct 13, 2025
Primary completionActual
Dec 21, 2025
CompletionEst.
Dec 2026
Last update
Jan 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06982599
Lead sponsor
Hanyang University
Collaborators
DSM-Firmenich AG
Responsible party
Yongsoon Park (Professor, Hanyang University) — Principal investigator
First posted
May 21, 2025
Start date
Oct 13, 2025
Primary completion
Dec 21, 2025
Completion
Dec 2026 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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