UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048652 |
|---|---|
| Receipt number | R000055432 |
| Scientific Title | An observational study of the relationship between oral bacterial flora and pneumonia among the elderly in two nursing homes |
| Date of disclosure of the study information | 2022/08/13 |
| Last modified on | 2022/08/12 13:45:36 |
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Basic information
Public title
A study of the relationship between oral bacterial flora and pneumonia among the elderly in nursing homes
Acronym
The association between oral microflora and pneumonia in the elderly
Scientific Title
An observational study of the relationship between oral bacterial flora and pneumonia among the elderly in two nursing homes
Scientific Title:Acronym
An observational study of the association between oral microflora and pneumonia in the elderly
Region
| Japan |
Condition
Condition
Pneumonia, Upper respiratory tract infection
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Relationship between oral microflora and pneumonia in the elderly
Basic objectives2
Others
Basic objectives -Others
Investigation of the relationship between oral microflora and pneumonia and upper respiratory tract infections in the elderly
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
History of pneumonia and upper respiratory tract infections
Key secondary outcomes
Oral bacterial flora,
Salivary IgA levels crossed with microorganisms that cause pneumonia and upper respiratory tract infections,
Herpes virus levels in saliva
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly residents in the two nursing homes under study
Key exclusion criteria
Elderly who are unable to collect saliva and tongue debris
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
2388580
Address
82 Inaoka-cho, 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
2388580
Address
82 Inaoka-cho, 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-cho, 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
寒川ホーム（神奈川県）
介護老人保健施設ほのぼの（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 13 | 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
107
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
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Coated tongue and saliva samples from elderly residents of nursing homes were collected and analyzed
Management information
Registered date
| 2022 | Year | 08 | Month | 12 | Day |
Last modified on
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055432
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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