UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034100 |
|---|---|
| Receipt number | 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 | 2022/02/09 16:34:59 |
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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 | Kei |
| Middle name | |
| Last name | Yamasaki |
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
kkyamsaki1019@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Nemoto |
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
kazuki585@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
| 2024 | Year | 07 | Month | 20 | 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
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038876
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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