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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name