UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051982 |
|---|---|
| Receipt number | R000059075 |
| Scientific Title | Study on the effects of food intake on oral microbiota. |
| Date of disclosure of the study information | 2023/08/27 |
| Last modified on | 2024/12/18 08:32:35 |
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Basic information
Public title
Evaluation of the effects of food intake on oral microbiota.
Acronym
Oral microbiota study
Scientific Title
Study on the effects of food intake on oral microbiota.
Scientific Title:Acronym
Oral microbiota study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of test substance intake for 4 weeks on oral microbiota in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Oral microbiota
Key secondary outcomes
Dental caries experience, oral hygiene status (dental plaque, tongue coating), snacking habits
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of tablets containing test substance, 3.0 g/day for 4 weeks
Interventions/Control_2
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
| 4 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy infants at screening test (4-5 years old)
2)Guardians receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1)Subjects who consciously use products claiming to be effective, such as test substance.
2)Subjects who regularly use toothpaste claiming that it contains test substance
3)Subjects who have been diagnosed with caries by screening tests
4)Subjects undergoing dental caries treatment
5)Subjects who have declared that they have an allergy to the research food
6)Guardians who are participating in the test of ingesting other foods or medicines, and those who are willing to participate
7)Subjects taking antibiotics or antibacterial agents, or who have taken them within 3 months of the screening test
8)Others who are judged by the investigator to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
eigyou27@kso.co.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
LOTTE 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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
柳澤デンタルオフィス(東京都)
Yanagisawa Dental Office
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 27 | 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
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 03 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 02 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059075
