UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056094 |
|---|---|
| Receipt number | R000064095 |
| Scientific Title | Comparison of the oral and lung microbiota to elucidate the oral-lung interaction |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 01:07:54 |
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Basic information
Public title
Comparison of the oral and lung microbiota to elucidate the oral-lung interaction
Acronym
Oral-Lung Microbiome study
Scientific Title
Comparison of the oral and lung microbiota to elucidate the oral-lung interaction
Scientific Title:Acronym
Oral-Lung Microbiome study
Region
| Japan |
Condition
Condition
Chronic lung diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the oral-lung microbiota interaction
Basic objectives2
Others
Basic objectives -Others
To identify potential primary prevention approaches to lung disease, focusing on oral management
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of microbiota in nasal, tongue coating, saliva, and bronchial fluids in the same patients
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients for whom bronchoscopy is performed for medical purposes.
(ii) Patients who fully understand the research plan and are able to give their consent.
Key exclusion criteria
(i) Patients with severe respiratory failure (on oxygen at Fi02 0.5 or above).
(ii) Other patients deemed unsuitable as research subjects by the principal investigator.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Keiko Kan-o |
| Middle name | |
| Last name | Keiko Kan-o |
Organization
Tokyo Women's Medical University
Division name
Department of Respiratory Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8112
konai.bm@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Kan-o |
Organization
Tokyo Women's Medical University
Division name
Department of Respiratory Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8112
Homepage URL
konai.bm@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Tokyo Women's Medical University
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
Tel
03-3353-8112
konai.bm@twmu.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
| 2024 | Year | 11 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064095
