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出境医 / 临床实验 / The Efficacy and Safety of SGF200 on Immune Enhancement

The Efficacy and Safety of SGF200 on Immune Enhancement

Study Description
Brief Summary:
This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.

Condition or disease Intervention/treatment Phase
Immunity Dietary Supplement: SGF200 group Dietary Supplement: Placebo Not Applicable

Detailed Description:
This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of SGF200 on Immune Enhancement
Actual Study Start Date : January 25, 2021
Actual Primary Completion Date : April 6, 2021
Actual Study Completion Date : May 26, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: SGF200 group
1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 1x10^9 CFU/day, GF101 200 U/day)]
 Dietary Supplement: SGF200 group
1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week
Placebo Comparator: placebo group
1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 0 CFU/day, GF101 0 U/day)]
 Dietary Supplement: Placebo
Placebo for 8 week
Outcome Measures
Primary Outcome Measures :
  1. Changes of Natural Killer cell activity [ Time Frame: 8 weeks ]

    Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1

    (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100



Secondary Outcome Measures :
  1. Changes of Cytokines [ Time Frame: 8 weeks ]

    For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes.

    Inspection item were IL-2, IL-12, IFN-γ, TNF-α.


  2. Changes of Wisconsin Upper Respiratory Symptom Survey-21 [ Time Frame: 8 weeks ]
    Wisconsin Upper Respiratory Symptom Survey-21 consists of seven steps, including individual symptoms, functional quality of life, and overall improvement. Find the sum of the symptom questions and give them the total score. Seek, sum up the questions of life, and get the total quality of life. The sum of the total score of symptoms and the total score of quality of life is also obtained.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult men and women over 50 years
  • After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

  • If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
  • Those who received influenza vaccination within 3 months before first intake for test product
  • Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
  • Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
  • Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
  • Those who have received antipsychotic medication within 3 months before screening
  • Those who alcoholic or drug abuse suspected
  • Those who participated in other clinical trials within 3 months before screening

  • Laboratory test by show the following results

    • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
    • Serum Creatinine > 2.0 mg/dL
  • Pregnancy or breast feeding
  • Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
  • Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Contacts and Locations

Locations
Layout table for location information
Korea, Republic of
Clinical Trial Center for Functional Foods Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 54907
Sponsors and Collaborators
Chonbuk National University Hospital
Tracking Information
First Submitted Date  ICMJE June 11, 2021
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE January 25, 2021
Actual Primary Completion Date April 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2021) 		Changes of Natural Killer cell activity [ Time Frame: 8 weeks ]
Natural Killer cell activity was measured in study baseline and 8 week. A ratio of effector cell and target cell was 2.5:1, 5:1, 10:1 (Experimental - Effector Spontaneous - Target Spontaneous) / (Target Maximum - Target Spontaneous) × 100
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • Changes of Cytokines [ Time Frame: 8 weeks ]
    For blood Cytokines analysis, collect 3 ml of blood in one SST tube for 5 ml, leave at room temperature for 30 minutes for clotting, after then centrifuge at 3000 rpm (or 2000 xg) for 10 minutes. Inspection item were IL-2, IL-12, IFN-γ, TNF-α.
  • Changes of Wisconsin Upper Respiratory Symptom Survey-21 [ Time Frame: 8 weeks ]
    Wisconsin Upper Respiratory Symptom Survey-21 consists of seven steps, including individual symptoms, functional quality of life, and overall improvement. Find the sum of the symptom questions and give them the total score. Seek, sum up the questions of life, and get the total quality of life. The sum of the total score of symptoms and the total score of quality of life is also obtained.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of SGF200 on Immune Enhancement
Official Title  ICMJE A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of SGF200 on Immune Enhancement
Brief Summary This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.
Detailed Description This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into SGF200 group or placebo group. The investigators measured Natural Killer cell activity, Cytokines(IL-2, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Immunity
Intervention  ICMJE
  • Dietary Supplement: SGF200 group
    1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week
  • Dietary Supplement: Placebo
    Placebo for 8 week
Study Arms  ICMJE
  • Experimental: SGF200 group
    1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 1x10^9 CFU/day, GF101 200 U/day)]
    Intervention: Dietary Supplement: SGF200 group
  • Placebo Comparator: placebo group
    1 times a day, 1 capsule for 1 time, before breakfast meal[350 mg/day (Bacillus amyloliquefaciens spore 0 CFU/day, GF101 0 U/day)]
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2021) 		100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 26, 2021
Actual Primary Completion Date April 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult men and women over 50 years
  • After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

  • If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
  • Those who received influenza vaccination within 3 months before first intake for test product
  • Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening
  • Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
  • Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
  • Those who have received antipsychotic medication within 3 months before screening
  • Those who alcoholic or drug abuse suspected
  • Those who participated in other clinical trials within 3 months before screening

  • Laboratory test by show the following results

    • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
    • Serum Creatinine > 2.0 mg/dL
  • Pregnancy or breast feeding
  • Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
  • Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04930640
Other Study ID Numbers  ICMJE BL-PI-SGF200
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soo-Wan Chae, Chonbuk National University Hospital
Study Sponsor  ICMJE Chonbuk National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chonbuk National University Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP