Human study to evaluate the effect and safety of oraCMS1 ? (Weissella cibaria CMS1) intake on upper respiratory infections and oral inflammation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005658

Enrollment

Registered

2020-12-03

Start date

2021-01-14

Completion date

Unknown

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : 12-week intake of oraCMS1 ? or placebo. (Randomized, double-blind, placebo-controlled human study)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: ?? 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.

Design outcomes

Primary

Measure	Time frame
Upper respiratory infection symptom questionnaire(WURSS-21);Biochemical biomarkers, oral microorganism;Vital sign;Clinical laboratory test(blood, urine)	—

Secondary

Measure	Time frame
Adverse event	—

Countries

Korea, Republic of

Contacts

Public ContactDanhee Kim

Seoul Metropolitan Government Seoul National University Boramae Medical Center

danhh2h@gmail.com+82-2-870-3844

Outcome results