Mood DisorderNCT06982599
Effects of Postbiotics on Mood Disorders in Korean Adults
A study testing postbiotics in people with Mood Disorder, run by Hanyang University at 1 site in South Korea.
Trial summary
This study was conducted to investigate effects of postbiotics on mood disorders in korean adults Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder
- What is being tested?
- postbiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Postbiotics on Mood Disorders in Korean Adults: Eight Week, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
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.
- Conditions
- Mood Disorder
- Being tested
- postbiotics, placebo
- Keywords
- mood disorder, postbiotics
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postbioticsDietary supplement
3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks
placeboDietary supplement
3 capsules/day placebo for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| postbiotics | Experimental | 3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks Receives: Dietary Supplement: postbiotics |
| Placebo | Placebo comparator | 3 capsules/day placebo for 8 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 0, week 8
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.
Measured: Three consecutive days at baseline (Week 0) and three consecutive days at follow-up (Week 8)
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.
Measured: week 0, week 8
Secondary outcomes (4)
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.
Measured: Week 0, Week 8
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.
Measured: Week 0, Week 8
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.
Measured: Week 0, Week 8
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.
Measured: Weekly from Week 0 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start13 Oct 2025
- Primary completion21 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Yongsoon Park, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982599
- Sponsor's protocol ID
- POST-LB-KR
- Other IDs
- HYUIRB-202503-008
- Status last verified
- Sep 2025
- First submitted
- 1 May 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Postbiotics on Mood Disorders in Korean Adults: Eight Week, Randomized Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial
- ClinicalTrials.gov ID
- NCT06982599
- Acronym / sponsor ID
- POST-LB-KR
- Conditions
- Mood Disorder
- Keywords
- mood disorder, postbiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postbiotics | Experimental | Dietary Supplement: postbiotics3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placebo3 capsules/day placebo for 8 weeks |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postbiotics3 capsules/day postbiotics (20 × 10^9 CFU/day) for 8 weeks | Dietary supplement | postbiotics |
| placebo3 capsules/day placebo for 8 weeks | Dietary supplement | Placebo |
Primary outcome
Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo
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.
Effect of postbiotics on momentary mood measured by Ecological Momentary Assessment (EMA), compared with placebo
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.
Effect of postbiotics on psychological distress measured by the Depression Anxiety Stress Scale-21 (DASS-21), compared with placebo
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.
4 secondary outcomes
Effect of postbiotics on perceived stress measured by the Perceived Stress Scale (PSS), compared with placebo
Time frame: Week 0, Week 8
Effect of postbiotics on fecal microbiome composition, compared with placebo
Time frame: Week 0, Week 8
Effect of postbiotics on fecal metabolites, compared with placebo
Time frame: Week 0, Week 8
Effect of postbiotics on gastrointestinal symptoms measured by the Irritable Bowel Syndrome Visual Analog Scale (VAS-IBS), compared with placebo
Time frame: Weekly from Week 0 to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postbiotics in people with Mood Disorder, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of postbiotics on depressive symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-D), compared with placebo (time frame: week 0, week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.