UMIN-CTR Clinical Trial

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
Email	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
Email	yamamoto.yuko@kdu.ac.jp

Sponsor
Institute	Kanagawa Dental University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055432