UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Metagenome analysis of normal middle ear cavity
Title of the study (Brief title)	Metagenome analysis of normal middle ear cavity
Region	Japan

Condition
Condition	non-infectous middle or inner ear disease
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify normal bacterial colony in the middle ear using metagenome
Basic objectives2	Others
Basic objectives -Others	To identify normal bacterial colony in the middle ear using metagenome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	N/A
Key secondary outcomes	N/A

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	otosclerosis auditory ossicular malformation severe sensorineural hearing loss bell's palsy perilymph fistula
Key exclusion criteria	patients who do not give informed consent
Target sample size	50

Research contact person
Name of lead principal investigator	Naoki Oishi
Organization	Keio University School of Medicine
Division name	Otolaryngology- head and neck surgery
Address	35 Shinanomachi, Shinjuku
TEL	03-5363-3827
Email	oishi_naoki@z5.keio.jp

Public contact
Name of contact person	Naoki Oishi
Organization	Keio University School of Medicine
Division name	Otolaryngology- head and neck surgery
Address	35 Shinanomachi, Shinjuku
TEL	03-5363-3827
Homepage URL
Email	oishi_naoki@z5.keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	National Hospital Organization
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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 06 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Metagenome analysis

Management information
Registered date	2014 Year 03 Month 28 Day
Last modified on	2018 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015832