UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057428 |
|---|---|
| Receipt number | R000065617 |
| Scientific Title | Study of the relationship between oral bacterial flora and pneumonia in nursing home elderly patients |
| Date of disclosure of the study information | 2025/03/27 |
| Last modified on | 2026/03/28 10:51:47 |
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Basic information
Public title
Study of the relationship between oral bacterial flora and pneumonia in nursing home elderly patients
Acronym
The association of oral bacteria and pneumonia in the elderly
Scientific Title
Study of the relationship between oral bacterial flora and pneumonia in nursing home elderly patients
Scientific Title:Acronym
The association of oral bacteria and pneumonia in the elderly
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between oral bacteria and the development of pneumonia in the elderly.
Basic objectives2
Others
Basic objectives -Others
To clarify the oral microflora of the elderly.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between oral bacteria and development of pneumonia
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
| 65 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly persons requiring nursing care who are admitted to the Samukawa Home and the elderly care center Honobono
Key exclusion criteria
Elderly persons who have been in the hospital for less than six months
Elderly persons who are continuously taking antibiotics
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 | 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
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Keiichi Tsukinoki
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
特別養護老人ホーム寒川ホーム（神奈川県）、老人保健施設ほのぼの（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | 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
101
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
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 10 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Relationship between Oral Bacteria and Development of Pneumonia in the Elderly
Prospective study
Management information
Registered date
| 2025 | Year | 03 | Month | 27 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065617
