UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044459 |
|---|---|
| Receipt number | R000050790 |
| Scientific Title | Differences in the oral and bronchial microbiome between patients with or without chronic obstructive pulmonary disease |
| Date of disclosure of the study information | 2021/06/09 |
| Last modified on | 2021/06/07 17:13:32 |
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Basic information
Public title
Differences in the oral and bronchial microbiome between patients with or without chronic obstructive pulmonary disease
Acronym
Differences in the oral and bronchial microbiome between patients with or without chronic obstructive pulmonary disease
Scientific Title
Differences in the oral and bronchial microbiome between patients with or without chronic obstructive pulmonary disease
Scientific Title:Acronym
Differences in the oral and bronchial microbiome between patients with or without chronic obstructive pulmonary disease
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the oral and bronchial microbiome between patients with or without COPD
Basic objectives2
Others
Basic objectives -Others
To identify the factors which affect the oral and bronchial microbiome in patients with COPD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences between the oral and bronchial microbiome in a patients
Key secondary outcomes
Differences in the oral and bronchial microbiome between patient with or without COPD
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo bronchoscopy after a pulmonary function test
Key exclusion criteria
Unstable respiratory failure
Infectious lung diseases
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyushu University Hospital
Division name
Department of Respiratory Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashiku, Fukuoka, Japan
TEL
0926425378
matsumoto.koichiro.723@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kan-o |
Organization
Kyushu University Hospital
Division name
Department of Respiratory Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashiku, Fukuoka, Japan
TEL
0926425378
Homepage URL
kan-o.keiko.641@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None
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
the Kyushu University Institutional Review Board for Clinical Research
Address
3-1-1 Maidashi, Higashiku, Fukuoka, Japan
Tel
0926425774
ijkseimei@jimu.kyushu-u.ac.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
| 2021 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection of samples from tongue coating, saliva, and epithelial lung fluid.
Collection of patient' medical information.
Management information
Registered date
| 2021 | Year | 06 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050790
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| Registered date | File name |
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| Registered date | File name |
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