UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Title of the study (Brief title)	Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Region	Japan

Condition
Condition	ALS
Classification by specialty	Pneumology Neurology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to study the difference of substance P concentrations in patients with ALS complicated with or without aspiration pneumonia.
Basic objectives2	Others
Basic objectives -Others	In order to study the effects of substance P production and development of pneumonia in patients with ALS.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Concentrations of substance P, bacteria in oral cavity
Key secondary outcomes	Vital sign, development of pneumonia

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ALS
Key exclusion criteria	No
Target sample size	40

Research contact person
Name of lead principal investigator	Atsuko Ohi
Organization	National Hospital Organization Hachinohe National Hospital
Division name	Clinical Nursing Research Section
Address	3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
TEL	0178-45-6111
Email

Public contact
Name of contact person	Mutsuo Yamaya
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Advanced Preventive Medicine for Infectious Disease
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
TEL	022-717-7184
Homepage URL
Email

Sponsor
Institute	National Hospital Organization Hachinohe National Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization Hachinohe National Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	国立病院機構八戸病院

Other administrative information
Date of disclosure of the study information	2011 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 18 Day
Anticipated trial start date	2011 Year 03 Month 01 Day
Last follow-up date	2013 Year 03 Month 01 Day
Date of closure to data entry	2017 Year 10 Month 03 Day
Date trial data considered complete	2017 Year 10 Month 03 Day
Date analysis concluded	2017 Year 10 Month 03 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	During the observation period, patients who received the oral care had fewer febrile days and lower frequency of the development of pneumonia. Salivary concentration of substance P was higher in the patients received the oral care. Geriatr Gerontol Int 13: 1082-1084, 2013.
Other related information	During the observation period, patients who received the oral care had fewer febrile days and lower frequency of the development of pneumonia. Salivary concentration of substance P was higher in the patients received the oral care. Geriatr Gerontol Int 13: 1082-1084, 2013.

Management information
Registered date	2011 Year 03 Month 30 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006350