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Completed

NCT Number: NCT05632341

GCWB1176 Evaluates the Effectiveness and Safety of 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.

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Key information

Conditions

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Lactococcus lactis

Dietary Supplement

1 capsule once a day

maltodextrin

Other

1 capsule once a day

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)

    Time frame: week -2, 0, 4 and 8

    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.

  2. Change amoust of WBC Count analysis

    Time frame: week -2, 0, 4 and 8

    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.

  3. Change amoust of FSS Count analysis

    Time frame: week -2, 0, 4 and 8

    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.

  4. Change amoust of upper respiratory infection analysis

    Time frame: week -2, 0, 4 and 8

    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.

Sponsors and collaborators

Lead sponsor

Green Cross Wellbeing

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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