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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05632341
Other study ID # GCWB110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 17, 2023
Est. completion date March 31, 2024

Study information

Verified date November 2022
Source Green Cross Wellbeing
Contact Yeongmin Kwon
Phone +82-70-8892-7881
Email ymkwon@gccorp.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Lactococcus lactis
1 capsule once a day
Other:
maltodextrin
1 capsule once a day

Locations

Country Name City State
Korea, Republic of Seoul St. Mary's Hospital, College of Medicine Seoul
Korea, Republic of St. Vincent's Hospital, College of Medicine Suwon-si

Sponsors (1)

Lead Sponsor Collaborator
Green Cross Wellbeing

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change amoust of Cytokine analysis (IFN-?, TNF-a, 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
Secondary 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
Secondary 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
Secondary 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
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