UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036868 |
|---|---|
| Receipt number | R000041890 |
| Scientific Title | Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia |
| Date of disclosure of the study information | 2019/05/29 |
| Last modified on | 2023/05/31 09:12:16 |
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Basic information
Public title
Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia
Acronym
Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia
Scientific Title
Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia
Scientific Title:Acronym
Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia
Region
| Japan |
Condition
Condition
idiopathic chronic fibrosing interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between lung microbiome and clinical course in patients with idiopathic chronic fibrosing interstitial pneumonia.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between lung microbiome and disease severity and cytokines in BALF.
To investigate a characteristics of microbiome at acute exacerbation.
To investigate cytokines in BALF and disease severity and clinical course.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between lung microbiome and time to respiratory hospitalization.
Key secondary outcomes
1. Relationship between lung microbiome and time to progression.
2. Characteristics of lung microbiome in patients with idiopathic chronic fibrosing interstitial pneumonia.
3. Relationship between lung microbiome and FVC % predicted.
4. Relationship between lung microbiome and PaO2.
5. Relationship between lung microbiome and KL-6.
6. Relationship between lung microbiome and decrease in FVC % predicted.
7. Relationship between lung microbiome and time to acute exacerbation.
8. Relationship between lung microbiome and causal microbe in patients who are hospitalized due to pneumonia or bronchitis.
9. Relationship between lung microbiome and time to death.
10. Characteristics of lung microbiome at acute exacerbation.
11. Relationship between lung microbiome and cytokines in BALF.
12. Relationship between cytokines in BALF and FVC % predicted, PaO2, KL-6, time to progression, time to respiratory hospitalization, time to acute exacerbation, and time to death.
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
1. Diagnosed with idiopathic chronic fibrosing interstitial pneuonia according to ATS/ERS/JRS/ALAT IPF guideline 2018 and/or ATS/ERS IIP statement 2013
2. No lung infection and acute exacerbation within 3 months
3. Written informed consent
Key exclusion criteria
1. Concomitant malignancy (eligible if cured)
2. Impossible to undergo pulmonary function tests
3. On long-term oxygen therapy (eligible ambulatory oxygen only)
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishiyama |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama, Osaka 589-8511, Japan
TEL
072-366-0221
nishi-o@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Nishiyama |
Organization
Kindai University, Faculty of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
589-8511
Address
377-2 Onohigashi, Osakasayama, Osaka 589-8511, Japan
TEL
072-366-0221
Homepage URL
nishi-o@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University, Faculty of Medicine, Department of Respiratory Medicine and Allergology
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Ethics committee of the Kindai University, Faculty of Medicine
Address
377-2 Onohigashi, Osakasayama, Osaka 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.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
近畿大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 29 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. We will evaluate lung microbiome in BALF which is obtained from patients with idiopathic chronic fibrosing interstitial pneumonia at diagnosis.
2. We will evaluate the patient's lung function every 6 months as general practice
3. When the patient is hospitalized due to acute exacerbation, we will obtain BALF as possible.
Management information
Registered date
| 2019 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041890
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
