UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013522 |
|---|---|
| Receipt number | 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 18:01:07 |
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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
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
shujirominami@me.com
Sponsor or person
Institute
National Tokyo Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015804
