UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between the oral assessment and the prevalence of pneumonia-causing bacteria for NST
Title of the study (Brief title)	Correlation between the oral assessment and pneumonia
Region	Japan

Condition
Condition	Undernutrition
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the relationship between the oral assessment and the prevalence of pneumonia-causing bacteria in nutritionally-depleted patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of pneumonia-causing bacteria
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	16 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients requiring NST intervention who were hospitalised at Kanazawa University Hospital between January 1, 2013, and June 30, 2013
Key exclusion criteria	Patients who can not obtain the imformed consent Patients with intense physical and mental exhaustion Doctor in charge judges it as inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	Toshiaki Tokumaru
Organization	Kanazawa University Hospital
Division name	Department of Nutrition Management
Address	13-1 Takara-machi, Kanazawa city, Ishikawa 920-8641, Japan
TEL	076-265-2000
Email	tkmr-knz@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Toshiaki Tokumaru
Organization	Kanazawa University Hospital
Division name	Department of Nutrition Management
Address	13-1 Takara-machi, Kanazawa city, Ishikawa 920-8641
TEL	076-265-2000
Homepage URL
Email	tkmr-knz@staff.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry	2013 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2018 Year 01 Month 20 Day
Last modified on	2018 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035263