UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057962 |
|---|---|
| Receipt number | R000066268 |
| Scientific Title | An observational study on the characteristics of oral microbiota in nursing home staff and its effects on the elderly |
| Date of disclosure of the study information | 2025/05/25 |
| Last modified on | 2025/05/25 22:31:48 |
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Basic information
Public title
An observational study of oral bacteria in nursing home staff
Acronym
Study on oral bacteria in nursing home staff
Scientific Title
An observational study on the characteristics of oral microbiota in nursing home staff and its effects on the elderly
Scientific Title:Acronym
An observational study investigating the characteristics of oral bacteria in nursing home staff
Region
| Japan |
Condition
Condition
Upper respiratory tract infection, Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the characteristics of the oral microbiota of nursing home staff who regularly consume yogurt with those who do not, and to clarify the effects on the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oral bacteria in tongue coating and antibacterial components in saliva
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nursing home staff with at least one year of experience working directly with elderly patients in medical or nursing care roles
Key exclusion criteria
Smoker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
Environmental Pathology
Zip code
238-8580
Address
82 Inaoka, Yokosuka, Kanagawa, Japan
TEL
0468228866
tsukinoki@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kanagawa Dental University
Division name
Junior College
Zip code
238-8580
Address
82 Inaoka, Yokosuka, Kanagawa, Japan
TEL
0468228755
Homepage URL
yamamoto.yuko@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Kanagawa Dental University
Address
82, Inaoka, Yokosuka, Kanagawa, Japan
Tel
0468228813
kenkyo@kdu.ac.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
| 2025 | Year | 05 | Month | 25 | 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
53
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Tongue and saliva samples were collected from 53 staff members who were continuously consuming yogurt and those who were not consuming yogurt.
Management information
Registered date
| 2025 | Year | 05 | Month | 25 | Day |
Last modified on
| 2025 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066268
