Unique ID issued by UMIN | UMIN000042297 |
---|---|
Receipt number | R000048288 |
Scientific Title | SP1665 |
Date of disclosure of the study information | 2020/10/30 |
Last modified on | 2022/08/25 09:40:48 |
Study on the relationship between oral volatile sulfur compounds and lactic acid bacteria.
Study on the relationship between bad breath and Lactobacillus.
SP1665
SP1665
Japan |
Healthy Adults
Adult |
Others
NO
To understand the kinetics of volatile sulfur compound generation in the human oral cavity while wearing a mask, and to study the effect of intake on the generation of volatile sulfur compounds.
Safety,Efficacy
Amount of change in oral gas concentration.
Analysis of oral flora (e.g. correlation with volatile sulfide compounds).
Interventional
Cross-over
Randomized
Cluster
Open -but assessor(s) are blinded
Placebo
2
Prevention
Food |
Beverage containing an ingredient.
Beverage without any ingredients.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) Subjects who gave written informed consent to participate in the study.
2) Individuals who are diagnosed as having no health problems based on a physician's interview.
3) Men and women aged 20-65 years at the time of informed consent.
4) Non-smokers for at least 1 year.
5) Persons who have not undergone dental treatment or cleaning by a dentist within 6 months retrospectively from the date of the screening examination.
6) Those who have 24 or more teeth left behind.
1) Pregnant women or women of childbearing potential, and women who wish to become pregnant during the study period.
2) Lactating women.
3) Persons with a history of serious disease (including Sjoegren's syndrome).
4) Persons who may require dental treatment (including orthodontic treatment) during the study participation period.
5) Persons who has undergone extraction procedures other than tooth extraction for convenience in wisdom tooth extraction or orthodontic treatment.
6) Patients who have taken antibiotics within 3 months.
7) Persons who may use antihistamines (due to hay fever, allergies, etc.) during the study period (use of antihistamines and cold medications will be investigated in a pre-questionnaire or diary).
8) Persons who do not show an increase in oral gas concentration after wearing a mask in the measurement of oral gas concentration during screening.
9) Other persons who the investigator or the investigator judges to be inappropriate as subjects of the study.
40
1st name | Hiroshi |
Middle name | |
Last name | Saito |
Otsuka Pharmaceutical,Co.,Ltd.
Otsu Nutraceuticals Research Institute
520-0002
3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
077-521-8835
Saito.Hiroshi@otsuka.jp
1st name | Hiroshi |
Middle name | |
Last name | Saito |
Otsuka Pharmaceutical,Co.,Ltd.
Otsu Nutraceuticals Research Institute
520-0002
3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
077-521-8835
Saito.Hiroshi@otsuka.jp
Otsuka Pharmaceutical,Co.,Ltd.
Otsuka Pharmaceutical,Co.,Ltd.
Profit organization
Japan Conference of Clinical Research
Ikebukuro YS Bldg. 8F, 1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022,Japan
03-6868-7022
ishii-keiko@3hcts.co.jp
NO
2020 | Year | 10 | Month | 30 | Day |
Unpublished
Completed
2020 | Year | 10 | Month | 23 | Day |
2020 | Year | 10 | Month | 16 | Day |
2020 | Year | 11 | Month | 05 | Day |
2021 | Year | 02 | Month | 28 | Day |
2021 | Year | 04 | Month | 27 | Day |
2021 | Year | 04 | Month | 27 | Day |
2020 | Year | 10 | Month | 30 | Day |
2022 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048288
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |