UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013522
Receipt No. R000015804
Scientific Title Metagenome analysis of chronic otitis media
Date of disclosure of the study information 2014/04/01
Last modified on 2020/09/29 (Ver. 6)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Metagenome analysis of chronic otitis media
Acronym Metagenome analysis of chronic otitis media
Scientific Title Metagenome analysis of chronic otitis media
Scientific Title:Acronym Metagenome analysis of chronic otitis media
Region
Japan

Condition
Condition Chronic otitis media
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the pathophysiology of chronic otitis media by metagenome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Metagenome analysis of chronic otitis media
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 Operative cases of chronic otitis media
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 shujirominami@me.com

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
2014 Year 04 Month 01 Day

Related information
URL releasing protocol DOI: 10.1002/lary.26579
Publication of results Published

Result
URL related to results and publications DOI: 10.1002/lary.26579
Number of participants that the trial has enrolled 155
Results 
The children and adults with normal middle ears differed significantly in terms of middle ear microbiomes. Subjects with chronic otitis media without active inflammation had similar middle ear microbiomes as the normal middle ears group. Subjects with chronic otitis media with active inflammation had a lower prevalence of Proteobacteria and a higher prevalence of Firmicutes than the normal middle ears.
Results date posted
2020 Year 09 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
All consecutive adult or pediatric patients undergoing tympanoplasty surgery for wet or dry COM or ear surgery for conditions other than otitis media between January 2014 and March 2015 were recruited prospectively into this study.
Participant flow 
All consecutive adult or pediatric patients undergoing tympanoplasty surgery for wet or dry COM or ear surgery for conditions other than otitis media between January 2014 and March 2015 were recruited prospectively into this study.
Adverse events 
No
Outcome measures 
The most abundant bacterial phyla on the mucosal surfaces of the normal middle ears were Proteobacteria, followed by Actinobacteria, Firmicutes, and Bacteroidetes. The children and adults with normal middle ears differed significantly in terms of middle ear microbiomes. 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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
2013 Year 12 Month 19 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2019 Year 01 Month 01 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
2014 Year 03 Month 26 Day
Last modified on
2020 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015804