Immune FunctionNCT05632341
GCWB1176 Evaluates the Effectiveness and Safety of Immune Function
A study testing Lactococcus lactis and maltodextrin in people with Immune Function, run by Green Cross Wellbeing at 2 sites in South Korea.
Trial summary
This human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Immune Function
- What is being tested?
- Lactococcus lactis and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 17 Jan 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of screening, 19 or 75 years
- A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μl
- Those who are more than one of the following standards
- Those who had more than twice within one year of visiting 1 year.
- {Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.
- Those who have stomatitis more than twice within 1 year of visit
Show all 9Show fewer
- Those who had Herpes Zoster infection within 1 year of visit
- Those with a stress awareness scale (PSS) 16 or more
- A person who agrees to participate in this human application test before the start of the human test and writes a written consent form
Who cannot join
- Those who are currently treating drugs due to underlying disease, etc.
- Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
- Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
- Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
- Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
- A disease that can affect immune responses such as adult -like and rhinitis
Show all 18Show fewer
- AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
- Those who are 1.5 times more than the normal upper limit of Creatinine
- Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.
- Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting
- A person who has administered or consumed lactic acid bacteria products (4 or more times a week) within 2 weeks of visiting within 2 weeks of visit.
- Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
- Those who are pregnant or have a planning plan for lactation or this human application period
- Those who have participated in other interventional clinical trials (including human application test) within 8 weeks of visit, or plan to participate in other interventional clinical trials (including human application tests) after the beginning of this human application test
- Those who are sensitive or allergic to food ingredients for this human application
- Those who have a BMI (body mass index) of 30 kg/m2 or more
- A person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week)
- Those who judge that the test person is inadequate for other reasons
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St. Mary's Hospital, College of Medicine
Seoul
St. Vincent's Hospital, College of Medicine
Suwon
About this study
Official title: GCWB1176 8 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Immune Function
This human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.
- Conditions
- Immune Function
- Being tested
- Lactococcus lactis, maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactococcus lactisDietary supplement
1 capsule once a day
maltodextrinOther
1 capsule once a day
| Study group | Role | What they receive |
|---|---|---|
| GCWB1176 | Experimental | 1 capsule once a day Receives: Dietary Supplement: Lactococcus lactis |
| Placebo | Active comparator | 1 capsule once a day Receives: Other: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change amoust of NK Cell Activity
The comparison of the military comparison for the change before and after the intake of NK CELL Activity is analyzed using the PAIRED T-TEST, and the degree of change between the test group and the control at at each point is Two Sample T-Test or Wilcoxon Rank Sum Test It is conducted to evaluate whether there is a statistically significant difference.
Measured: week 0, 4 and 8
Secondary outcomes (4)
Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)
The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference.
Measured: week -2, 0, 4 and 8
Change amoust of WBC Count analysis
The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference.
Measured: week -2, 0, 4 and 8
Change amoust of FSS Count analysis
The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference.
Measured: week -2, 0, 4 and 8
Change amoust of upper respiratory infection analysis
The comparison of the military in the before and after consumption is analyzed using the PAIIRED T-TEST, and the degree of change between the test group and the control group at each time is performed by performing the two sample T-test or the Wilcoxon Rank Sum Test according to whether the normality is satisfied. Evaluate if there is a significant difference.
If there is a statistically significant difference between the military and clinically significantly significantly significant differences in demographic and lifestyle surveys, ANCOVA can be carried out as a covenant.
Measured: week -2, 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start17 Jan 2023
- Primary completion31 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune FunctionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Wellbeing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632341
- Sponsor's protocol ID
- GCWB110
- Status last verified
- Feb 2026
- First submitted
- 11 Nov 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCWB1176 8 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Immune Function
- ClinicalTrials.gov ID
- NCT05632341
- Acronym / sponsor ID
- GCWB110
- Conditions
- Immune Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Green Cross WellbeingIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 30 Nov 2022 (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 human application test was planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCWB1176 | Experimental | Dietary Supplement: Lactococcus lactis1 capsule once a day |
| Placebo | Active comparator | Other: maltodextrin1 capsule once a day |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At the time of screening, 19 or 75 years
- A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μl
- Those who are more than one of the following standards
- Those with a stress awareness scale (PSS) 16 or more
- A person who agrees to participate in this human application test before the start of the human test and writes a written consent form
Key exclusion criteria (18 listed)
- Those who are currently treating drugs due to underlying disease, etc.
- Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
- Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
- Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
- Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
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 |
|---|---|---|
| Lactococcus lactis1 capsule once a day | Dietary supplement | GCWB1176 |
| maltodextrin1 capsule once a day | Other | Placebo |
Primary outcome
Change amoust of NK Cell Activity
Time frame: week 0, 4 and 8
The comparison of the military comparison for the change before and after the intake of NK CELL Activity is analyzed using the PAIRED T-TEST, and the degree of change between the test group and the control at at each point is Two Sample T-Test or Wilcoxon Rank Sum Test It is conducted to evaluate whether there is a statistically significant difference.
4 secondary outcomes
Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)
Time frame: week -2, 0, 4 and 8
Change amoust of WBC Count analysis
Time frame: week -2, 0, 4 and 8
Change amoust of FSS Count analysis
Time frame: week -2, 0, 4 and 8
Change amoust of upper respiratory infection analysis
Time frame: week -2, 0, 4 and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactococcus lactis and maltodextrin in people with Immune Function, run by Green Cross Wellbeing at 2 sites 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change amoust of NK Cell Activity (time frame: week 0, 4 and 8). 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 23 Feb 2026.