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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005344
Receipt No. R000006350
Scientific Title Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Date of disclosure of the study information 2011/03/30
Last modified on 2018/10/04

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Basic information
Public title Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Acronym Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Scientific Title Studies on the relationship between aspiration pneumonia and substance P in patients with ALS
Scientific Title:Acronym 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
1st name
Middle name
Last name Atsuko Ohi
Organization National Hospital Organization Hachinohe National Hospital
Division name Clinical Nursing Research Section
Zip code
Address 3-13-1 Fukiage, Hachinohe City, Aomori Prefecture, 031-0003, Japan
TEL 0178-45-6111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mutsuo Yamaya
Organization Tohoku University Graduate School of Medicine
Division name Department of Advanced Preventive Medicine for Infectious Disease
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2011 Year 02 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000006350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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