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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036868
Receipt No. R000041890
Scientific Title Lung microbiome in idiopathic chronic fibrosing interstitial pneumonia
Date of disclosure of the study information 2019/05/29
Last modified on 2019/05/28

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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
Email 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
Email nishi-o@med.kindai.ac.jp

Sponsor
Institute Kindai University, Faculty of Medicine, Department of Respiratory Medicine and Allergology
Institute
Department

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
Email 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 Preinitiation
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
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
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041890

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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