Human study to evaluate the effect and safety of oraCMS1 ? (Weissella cibaria CMS1) intake on upper respiratory infections and oral inflammatio
- Conditions
- Not Applicable
- Registration Number
- KCT0005658
- Lead Sponsor
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
1) Subject who agreed to participate in this study and signed a written informed consent
2) Subject aged from 20 to under 70
3) Subject who have had upper respiratory infections or flu symptoms at least 4 times a year
??
1) Subject with symptoms of upper respiratory infection, flu, or suspected COVID-19 infection at the
first visit
2) Subject with current clinically significant cardiovascular, immune system, infectious, neoplastic,
respiratory system diseases
3) Subject with a history of peritonsillar abscess, rheumatic fever, or glomerulonephritis
4) Subject with severe gastrointestinal symptoms, gastrointestinal diseases, or have undergone
gastrointestinal surgery
5) Subject who are being treated for uncontrolled hypertension, diabetes, thyroid disease, etc.
6) Subject with mental illness such as depression, schizophrenia, alcoholism, drug addiction, etc.
7) Subject with serum creatinine is more than twice the normal upper limit of the research institute or
those whose ALT and AST levels are more than three times the normal upper limit of the research
institute
8) Subject who received antibiotics or drugs that may affect immune function within 1 month of the
first visit
9) Subject who have consistently consumed probiotics products or health functional foods that may
affect immunity within one month of the first visit.
etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pper respiratory infection symptom questionnaire(WURSS-21);Biochemical biomarkers, oral microorganism;Vital sign;Clinical laboratory test(blood, urine)
- Secondary Outcome Measures
Name Time Method Adverse event