UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of the pharyngeal microbiome
Acronym	The analysis of the pharyngeal microbiome
Scientific Title	The analysis of the pharyngeal microbiome
Scientific Title:Acronym	The analysis of the pharyngeal microbiome
Region	Japan

Condition
Condition	Patients of infectious diseases and healthy individuals
Classification by specialty	Medicine in general Infectious disease Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Characterizing the pharyngeal microbiome
Basic objectives2	Others
Basic objectives -Others	Characterizing the pharyngeal microbiome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Characterizing the pharyngeal microbiome
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients from Toho University Omori Medical Center, Department of General Medicine and Emergency Care.
Key exclusion criteria	Individuals with acute respiratory symptoms or those who used antibiotics within the last 4 weeks were excluded. We also excluded individuals with a history of palatine tonsillectomy or those who were unable to be sampled correctly for anatomical reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kazuhiro Middle name Last name Tateda
Organization	Toho University
Division name	Department of Microbiology and Infectious Diseases
Zip code	143-8540
Address	5-21-16 Omorinishi, Ota-ku, Tokyo 143-8540, Japan
TEL	0337624151
Email	kazu@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yuto Middle name Last name Fukui
Organization	Toho University
Division name	Department of Microbiology and Infectious Diseases
Zip code	143-8540
Address	5-21-16 Omorinishi, Ota-ku, Tokyo 143-8540, Japan
TEL	0337624151
Homepage URL
Email	yuuto.fukui@med.toho-u.ac.jp

Sponsor
Institute	Toho University
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	Toho University
Address	5-21-16 Omorinishi, Ota-ku, Tokyo 143-8540, Japan
Tel	0337624151
Email	med.rinri@ext.toho-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	2017 Year 12 Month 25 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	Main results already published
Date of protocol fixation	2016 Year 09 Month 30 Day
Date of IRB	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A single center prospective observational study

Management information
Registered date	2017 Year 12 Month 24 Day
Last modified on	2019 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034874