The Efficacy and Safety of SGF200 on Immune Enhancement

NCT04930640 | Completed DMC

• 1 other identifier: BL-PI-SGF200
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to investigate the efficacy and safety of SGF200 on immune enhancement.

Conditions

Immunity

Keywords

SGF200

Outcome Measures

Primary Outcomes (1)

• Changes of Natural Killer cell activity

  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

  8 weeks

Secondary Outcomes (2)

• Changes of Cytokines

  8 weeks

• Changes of Wisconsin Upper Respiratory Symptom Survey-21

  8 weeks

Study Arms (2)

SGF200 group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Interventions

SGF200 group DIETARY_SUPPLEMENT

1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week

SGF200 group

Placebo DIETARY_SUPPLEMENT

Placebo for 8 week

placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: January 25, 2021
• Primary Completion: April 6, 2021
• Study Completion: May 26, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

KR (1)