UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049222 |
|---|---|
| Receipt number | R000056062 |
| Scientific Title | Effect of continuous intake of the test food on oral flora -A randomized double-blind cross-over study- |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2024/01/12 10:08:52 |
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Basic information
Public title
Effect of the test food on oral flora
Acronym
Effect of the test food on oral flora
Scientific Title
Effect of continuous intake of the test food on oral flora -A randomized double-blind cross-over study-
Scientific Title:Acronym
Effect of continuous intake of the test food on oral flora
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the effects of continuous intake of the test food for 4 weeks on the oral flora of healthy men and women, aged 20 to 59 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Number and ratio of periodontal disease-related bacteria in saliva
2) Number and ratio of caries-related bacteria in saliva
Key secondary outcomes
1) Change in the number and ratio of periodontal disease-related bacteria in saliva
2) Change in the number and ratio of caries-related bacteria in saliva
3) Total number of bacteria in saliva and its change
4) Salivary pH and its change
5) Oral moisture level and its change
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
4 weeks intake of the test food 1
Interventions/Control_2
4 weeks intake of the test food 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age in the range of 20 to < 60
2) Non smokers
3) Healthy men and women
Key exclusion criteria
1) Subject who is currently receiving any medications or outpatient treatment
2) Subjects who are currently going to the dentist for reasons other than regular health checkups such as dental caries and periodontal disease
3) Subjects who regularly use foods and medicines that can be expected to improve the oral flora and oral environment
4) Subject who is may develop allergy due to the test food
5) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period
6) Subjects currently participating in other clinical trials or willing to participate in other clinical trials during the study period
7) Other than the above, subjects who are judged to be ineligible for this study by the principal investigator or the study supervisor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
m-kobayasi@itoen.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Tanaka |
Organization
ITO EN, Ltd.
Division name
Central Research Institute
Zip code
421-0516
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL
0548-54-1247
Homepage URL
ya-tanaka@itoen.co.jp
Sponsor or person
Institute
ITO EN, Ltd.
Institute
Department
Personal name
Funding Source
Organization
ITO EN, Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, ITO EN, Ltd.
Address
21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
Tel
0548-54-1247
h-hosoyama@itoen.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
| 2022 | Year | 11 | Month | 07 | 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
20
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
| 2022 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 06 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056062
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