GCWB1176 Evaluates the Effectiveness and Safety of Immune Function

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.

Study Overview

• Status: Completed
• Conditions: Immune Function
• Intervention / Treatment: Dietary supplement: Lactococcus lactis; Other: maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul St. Mary's Hospital, College of Medicine
  • Suwon, South Korea
    • St. Vincent's Hospital, College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At the time of screening, 19 or 75 years
2. A person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μl

3. 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

         • Those who had Herpes Zoster infection within 1 year of visit
4. Those with a stress awareness scale (PSS) 16 or more
5. A person who agrees to participate in this human application test before the start of the human test and writes a written consent form

Exclusion Criteria:

1. Those who are currently treating drugs due to underlying disease, etc.
2. Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
3. Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
4. Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
5. Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
6. A disease that can affect immune responses such as adult -like and rhinitis
7. AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
8. Those who are 1.5 times more than the normal upper limit of Creatinine
9. Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.
10. Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting
11. 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.
12. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
13. Those who are pregnant or have a planning plan for lactation or this human application period
14. 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
15. Those who are sensitive or allergic to food ingredients for this human application
16. Those who have a BMI (body mass index) of 30 kg/m2 or more
17. A person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week)
18. Those who judge that the test person is inadequate for other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GCWB1176; 1 capsule once a day	Dietary supplement: Lactococcus lactis; 1 capsule once a day
Active Comparator: Placebo; 1 capsule once a day	Other: maltodextrin; 1 capsule once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 0, 4 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	week -2, 0, 4 and 8

Collaborators and Investigators

• Sponsor: Green Cross Wellbeing

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: maltodextrin
• Other Study ID Numbers: GCWB110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No