Effects of probiotic bacterium Weissella cibaria CMU on oral health and psychosocial health
- Conditions
- Not Applicable
- Registration Number
- KCT0005078
- Lead Sponsor
- Kangwon National University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 68
1) The person with written consent and acceptable communication capacity
2) The person with 20 years old more
3) The person with 20 natural teeth more
4) The person without tongue health problem (tongue cancer, tongue inflammation, etc.)
5) The person with more tnan 1.5 ng/10ml of VSC (H2S, CH3SH, (CH3)2S)
1) The person with less than 80%(total intake of 44.8 tablets) compliance of study regimen (total intake of 56 tablets)
2) The person without ability of communicattion in spite of aids of glasses, magnifying glass, hearing-aid
3) The person with mental health problem (schizophrenia, mental retardation, etc.)
4) The person with treatment of systemic health problem causing halitosis (liver disease, kidney disease, Sjögren syndrome, rheumatism, etc.)
5) The person with diagnosis of rhinitis or sinus infection
6) The person with taking antibiotics (correspond to taking during this study, within 2 weeks after screening, or within last 1 month)
7) The person with more than 3 times of normal range of GOT and GPT
8) The person with more than 2 times of normal range of BUN/Creatinine
9) The person with diagnosis of chronic gastritis
10) The person with uncontrollerable high blood pressure (SBP 160mmHg higher or DBP 100mmHg higher)
11) The person with more than 126mg/dL of fasting blood sugar (FBS) or 200mg/dL of random glucose, or current DMpatient with taking insulin or oral hypoglycemic agent
12) The person with continuous intake of oral probiotic related health medicinal products within a week after screening
13) The person with sensitivity or alllergy by probiotic products including dairy product
14) The person with participation to the other human application clinical trial within last 4 weeks
15) The person to be thought Inappropriate in this human application study by research team's judgement
16) The person with taking Warfarin or Aspirin
17) The person with risk of aspiration
18) The person with xerostomia
19) The person with severe perodontal health problem or multiple dental carries, and 5 more dental caries with need of prompt treatment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VSC via Oral Chroma;Organoleptic test;Self perception of bad breath improvement;Bleeding on probing;Probing depth;Gingival index;Plaque index
- Secondary Outcome Measures
Name Time Method microorganism count: peridontal bacteria and Weissella cibaria;depression;self-esteem;oral health related quality of life;perceived oral health.;The safety index: Vital signs(Blood pressure, pulse, body temperature), Liver funtion test, Kidey fuction test, Complete blood count, Abnormal reaction survey.