GCWB1176 Evaluates the Effectiveness and Safety of Immune Function

NCT ID: NCT05632341

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2024-03-31

Brief 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.

Conditions

Immune Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

GCWB1176

1 capsule once a day

Group Type: EXPERIMENTAL

Lactococcus lactis

Intervention Type: DIETARY_SUPPLEMENT

1 capsule once a day

Placebo

1 capsule once a day

Group Type: ACTIVE_COMPARATOR

maltodextrin

Intervention Type: OTHER

1 capsule once a day

Interventions

Lactococcus lactis

1 capsule once a day

Intervention Type: DIETARY_SUPPLEMENT

maltodextrin

1 capsule once a day

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Wellbeing

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul St. Mary's Hospital, College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

St. Vincent's Hospital, College of Medicine

Suwon, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Yeongmin Kwon

Role: CONTACT

ymkwon@gccorp.com

+82-70-8892-7881

Facility Contacts

Kyung-soo Kim, Ph. D

Role: primary

Sang-Wook Song, Ph. D

Role: primary

Other Identifiers

GCWB110

Identifier Type: -

Identifier Source: org_study_id