UMIN-CTR Clinical Trial

Basic information
Public title	Metagenome analysis of otorrhea
Acronym	Metagenome analysis of otorrhea
Scientific Title	Metagenome analysis of otorrhea
Scientific Title:Acronym	Metagenome analysis of otorrhea
Region	Japan

Condition
Condition	Chronic otitis media, Acute otitis media, external otitis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the bacterial flora of otorrhea by metagenome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metagenome analysis of otorrhea
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with otorrhea
Key exclusion criteria	no
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shujiro Middle name Last name Minami
Organization	National Tokyo Medical Center
Division name	Department of otolaryngology
Zip code	152-8902
Address	2-5-1 Higashigaoka Meguroku Tokyo
TEL	03-3411-0111
Email	shujirominami@me.com

Public contact
Name of contact person	1st name Shujiro Middle name Last name Minami
Organization	National Tokyo Medical Center
Division name	Department of otolaryngology
Zip code	152-8902
Address	2-5-1 Higashigaoka Meguroku Tokyo
TEL	03-3411-0111
Homepage URL
Email	shujirominami@me.com

Sponsor
Institute	National Tokyo Medical Center
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)

IRB Contact (For public release)
Organization	National Hospital Organization Tokyo Medical Center
Address	2-5-1 Higashigaoka Meguroku Tokyo
Tel	03-3411-0111
Email	215-rinri@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000019722
Publication of results	Unpublished

Result
URL related to results and publications	10.1002/lary.26579
Number of participants that the trial has enrolled	155
Results	Subjects with chronic otitis media without active inflammation (dry ear) had similar middle ear microbiomes as the normal middle ears group. Subjects with chronic otitis media with active inflammation (wet ear) had a lower prevalence of Proteobacteria and a higher prevalence of Firmicutes than the normal middle ears.
Results date posted	2021 Year 04 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Active inflammation with otorrhea was noted in 44 of 88 patients with chronic otitis media.
Participant flow	Active inflammation with otorrhea was noted in 44 of 88 patients with chronic otitis media.
Adverse events	No
Outcome measures	The variable region 4 of the 16S rRNA gene in each sample were amplified using region-specific primers adapted for the Illumina MiSeq sequencer. The sequences were subjected to local blast and classified
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 03 Month 31 Day
Date of IRB	2015 Year 03 Month 03 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Outcome of metagenome analysis

Management information
Registered date	2015 Year 03 Month 31 Day
Last modified on	2021 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019722