UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039374 |
|---|---|
| Receipt number | R000044771 |
| Scientific Title | The effects of intestinal flora on the development and prognosis of pulmonary nontuberculous mycobacteriosis. |
| Date of disclosure of the study information | 2020/02/10 |
| Last modified on | 2020/02/03 13:14:41 |
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Basic information
Public title
The effects of intestinal flora on the development and prognosis of pulmonary nontuberculous mycobacteriosis.
Acronym
Relationship between intestinal flora and pulmonary nontuberculous mycobacteriosis.
Scientific Title
The effects of intestinal flora on the development and prognosis of pulmonary nontuberculous mycobacteriosis.
Scientific Title:Acronym
Relationship between intestinal flora and pulmonary nontuberculous mycobacteriosis.
Region
| Japan |
Condition
Condition
Pulmonary nontuberculous mycobacteriosis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the effects of intestinal flora on the development and prognosis of pulmonary nontuberculous mycobacteriosis.
Basic objectives2
Others
Basic objectives -Others
To analyze the relationship between the therapeutic effect on pulmonary nontuberculous mycobacteriosis and the intestinal flora.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of intestinal flora on the development and prognosis of pulmonary nontuberculous mycobacteriosis.
Key secondary outcomes
The relationship between therapeutic effects on pulmonary nontuberculous mycobacteriosis and intestinal flora.
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. Inpatient/Outpatient: unquestioned.
2. Patients with pulmonary opacities such as nodular shadow, granular shadow, bronchiectasis, cavity shadow, or infiltration witch are characteristic for pulmonary nontuberculous mycobacteriosis.
3. Patients who have been given sufficient explanations to participate in this study, and with sufficient understanding and who have given their informed consent.
Key exclusion criteria
1. Patients who have received antibiotic treatment within the last two months.
2. Patients judged to be inappropriate as research subjects by researchers.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Imamura |
Organization
Department of Respiratory Medicine
Division name
Nagasaki University Hospital
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7273
yimamura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Imamura |
Organization
Department of Respiratory Medicine
Division name
Nagasaki University Hospital
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-819-7273
Homepage URL
yimamura@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
| 2020 | Year | 02 | Month | 10 | 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
| 2019 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with clinically suspected pulmonary Non-tuberculous mycobacteriosis (NTM) disease are to be entered and routinely examined to divide them into pulmonary NTM disease group and non-pulmonary NTM disease group. A case-control study will be conducted between these two groups. Stool collection will be performed at outpatient visits and at the time of hospitalization for the purpose of examination or induction of treatment, and the stool flora will be analyzed using the next-generation sequencer at the National Institute of Health Sciences, National Institute of Health Sciences and Nutrition. In addition, we will conduct surveys using questionnaires on patient background, eating habits, and lifestyle habits. For these collected items, we will compare the pulmonary NTM disease group with the non-pulmonary NTM disease group to analyze the relationship between the onset and treatment of pulmonary NTM disease and the intestinal flora.
In addition, for patients who started standard treatment for pulmonary NTM disease under normal medical care after participating in this study, 3 to 6 months after the start of treatment, the efficacy of treatment by chest CT examination and the change of intestinal microflora will be analyzed.
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044771
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