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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034100
Receipt No. R000038876
Scientific Title Role of microbiome in the pathogenesis and progression of chronic pulmonary aspergillosis using a clone library analysis of 16S rRNA gene
Date of disclosure of the study information 2018/09/11
Last modified on 2019/03/13

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Basic information
Public title Role of microbiome in the pathogenesis and progression of chronic pulmonary aspergillosis using a clone library analysis of 16S rRNA gene
Acronym Role of microbiome in the pathogenesis and progression of chronic pulmonary aspergillosis using a clone library analysis of 16S rRNA gene
Scientific Title Role of microbiome in the pathogenesis and progression of chronic pulmonary aspergillosis using a clone library analysis of 16S rRNA gene
Scientific Title:Acronym Role of microbiome in the pathogenesis and progression of chronic pulmonary aspergillosis using a clone library analysis of 16S rRNA gene
Region
Japan

Condition
Condition chronic pulmonary aspergillosis
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the microbiome in bronchoalveolar lavage fluid (BALF) of the pulmonary lesions obtained from patients with chronic pulmonary aspergillosis and the relationship between the microbiome and the pathogenesis (clinical features, chest CT findings or disease type) or the progression (prognosis, duration of disease, and clinical response to antimicrobial drugs).
We also evaluate the ability of phagocytosis against coexisting bacteria and fungi decline and the ability to differentiate functional macrophages, such as M1 and M2 macrophages in patients with chronic pulmonary aspergillosis that have deteriorated rapidly.
Basic objectives2 Others
Basic objectives -Others We evaluate the relationship between bacterial phylotype that is detected using the bacterial flora analysis and chest CT findings of patient with chronic pulmonary aspergillosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between microbiome and chest CT findings of patients with chronic pulmonary aspergillosis.
Key secondary outcomes We evaluate the following problems at the start of the test and 24 to 28 weeks and 48 to 52 weeks after this trial started.

1) Clinical manifestations, laboratory findings

2) Microbiological evaluation:
Transition of causative bacteria with sputum

3) Cytokines, oxidative stress markers in BALF (including TNF-a, NOS, HO-1, IL-4, IL-6, IL-8, IL-13 and others).

4) The time-dependent change of the CT findings

5) The statistically significant differences in the differentiation ability according to the macrophages phenotypes (proportion of macrophages phenotype), and the CT findings.

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 Patients with suspected chronic pulmonary aspergillosis and do not conflict with the exclusion criteria are registered.
We use the criteria of the Guidelines for Management of Deep-seated Mycoses in Japan were revised in February 2014 to diagnosis chronic pulmonary aspergillosis.
Patients who are positive for serum anti-Aspergillus sedimentation antibody, Aspergillus GM antigen, B-D glucan or histopathological findings are defined clinical diagnosis.
Patients who are positive for culture tests are defined confirmed diagnosis.
Key exclusion criteria The following patients are excluded.
1. Patients who do not agree with this study
2. Patients for whom bronchoscopy is difficult to preform because of comorbidity and who do not agree with bronchoscopy
3. Patients who received antibiotic therapy within 3 days before bronchoscopy. (Excluding small-volume long-term therapy of macrolide drugs)
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Toshinori
Middle name
Last name Kawanami
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL 093-691-7453
Email namihei@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Ikegami
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine
Zip code 807-8555
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
TEL 093-691-7453
Homepage URL
Email h_i214538y@yahoo.co.jp

Sponsor
Institute Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization None
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 Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu city, Fukuoka, 807-8555, Japan
Tel 093-691-7205
Email daigakukanri@mbox.pub.uoeh-u.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
2018 Year 09 Month 11 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
2018 Year 09 Month 05 Day
Date of IRB
2018 Year 11 Month 19 Day
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This clinical trial is a prospective observational study. Patients who meet selection criteria and do not conflict with exclusion criteria are included.

This study is scheduled to end in July 2021.

Management information
Registered date
2018 Year 09 Month 11 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038876

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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