UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022428 |
|---|---|
| Receipt number | R000025848 |
| Scientific Title | A prospective observational study of lung microbiome in pulmonary diseases |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2023/08/29 09:47:16 |
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Basic information
Public title
A prospective observational study of lung microbiome in pulmonary diseases
Acronym
Lung microbiome in pulmonary diseases
Scientific Title
A prospective observational study of lung microbiome in pulmonary diseases
Scientific Title:Acronym
Lung microbiome in pulmonary diseases
Region
| Japan |
Condition
Condition
pulmonary diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the relationship between the pulmonary disease and microbiome in upper and lower airway.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We identify the specific microbiome pattern from patients' bronchoalveolar lavage fluid.
Key secondary outcomes
We study the relationship between microbiome and patients' labo data (WBC, SP-A and SP-D).
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
Pulmonary disease patients who need examination to diagnose.
Key exclusion criteria
Patients who are difficult to examine the lower airway.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Kuronuma |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Respiratory medicine and allergology
Zip code
060-8543
Address
S1W16 Chuo-ku Sapporo Hokkaido
TEL
011-611-2111
kuronumak@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Youhei |
| Middle name | |
| Last name | Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Respiratory medicine and allergology
Zip code
060-8543
Address
S1W16 Chuo-ku Sapporo Hokkaido
TEL
011-611-2111
Homepage URL
kuronumak@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Clinical Trial Center
Address
S1W16 Chuo-ku Sapporo Hokkaido
Tel
011-611-2111
akifujito@sapmed.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
| 2016 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://web.sapmed.ac.jp/im3/research/f1dnqs00000004db.html
Publication of results
Published
Result
URL related to results and publications
https://respiratory-research.biomedcentral.com/articles/10.1186/s12931-018-0736-9
Number of participants that the trial has enrolled
130
Results
Impaired diversity of the lung microbiome predicts progression of idiopathic pulmonary fibrosis.
Results date posted
| 2023 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
130 patients
Participant flow
130 patients
Adverse events
None
Outcome measures
Impaired diversity of the lung microbiome predicts progression of idiopathic pulmonary fibrosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pulmonary disease patients who need examination to diagnose.
Management information
Registered date
| 2016 | Year | 05 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025848
