UMIN-CTR Clinical Trial

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
Email	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
Email	yimamura@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044771