UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043042 |
|---|---|
| Receipt number | R000049140 |
| Scientific Title | Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria. |
| Date of disclosure of the study information | 2021/01/19 |
| Last modified on | 2022/08/25 09:41:53 |
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Basic information
Public title
Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria.
Acronym
Study on the relationship between breath odors and chewy foods containing lactic acid bacteria.
Scientific Title
Study on the relationship between oral volatile sulfur compounds and chewy foods containing lactic acid bacteria.
Scientific Title:Acronym
Study on the relationship between breath odors and chewy foods containing lactic acid bacteria.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ingestion of chewy foods containing lactic acid bacteria on the generation of volatile sulfur compounds during masking. At the same time, changes in physical condition, etc. will be confirmed in order to understand the improvement of immune-related QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in oral gas concentration.
Key secondary outcomes
Analysis of oral flora (e.g. correlation with volatile sulfide compounds).
Immune-related changes in quality of life.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing active ingredients, 4pieces /day, 28 consecutive days.
Interventions/Control_2
Food without active ingredients, 4pieces /day, 28 consecutive days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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 with a history of hypersensitivity to gelatin or sugar alcohols.
5) Persons who may require dental treatment (including orthodontic treatment) during the study participation period.
6) Persons who has undergone extraction procedures other than tooth extraction for convenience in wisdom tooth extraction or orthodontic treatment.
7) Patients who have taken antibiotics (antibiotics/antibiotics) within 3 months.
8) 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).
9) Persons who do not show an increase in oral gas concentration after wearing a mask in the measurement of oral gas concentration during screening.
10) Other persons who the investigator or the investigator judges to be inappropriate as subjects of the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical,Co.,Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
TEL
077-521-8835
Saito.Hiroshi@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Saito |
Organization
Otsuka Pharmaceutical,Co.,Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saikawa, Otsu-shi, Shiga 520-0002, Japan
TEL
077-521-8835
Homepage URL
Saito.Hiroshi@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical,Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical,Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
Ikebukuro YS Bldg. 8F, 1-13-23 Minami-ikebukuro, Toshima-ku, Tokyo 171-0022,Japan
Tel
03-6868-7022
ishii-keiko@3hcts.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
| 2021 | Year | 05 | Month | 27 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 18 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049140
