UMIN-CTR Clinical Trial

Basic information
Public title	Influence of preservation environments on salivary microbiota profiles in 16S rRNA sequencing
Acronym	Influence of preservation environments on salivary microbiota profiles in 16S rRNA sequencing
Scientific Title	Influence of preservation environments on salivary microbiota profiles in 16S rRNA sequencing
Scientific Title:Acronym	Influence of preservation environments on salivary microbiota profiles in 16S rRNA sequencing
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the microbial profiles based on 16S rRNA sequencing between storing temperatures
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Microbial profiles based on 16S rRNA amplicon sequencing
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subjects who participated in the study entitled "Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases UMIN000040192" from April 1, 2017 to March 31, 2019, and underwent salivary microbiota analysis.
Key exclusion criteria	1. those whose salivary samples were not or could not be stored in the respective storage environments 2. those who refused to participate by opting out
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Furuhashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	0336331111
Email	ms04furuhashi@jikei.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Furuhashi
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code	1058471
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL	0336331111
Homepage URL
Email	ms04furuhashi@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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	The Jikei University School of Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel	0336331111
Email	rinri@jikei.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	2021 Year 04 Month 02 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	5
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	No longer recruiting
Date of protocol fixation	2020 Year 10 Month 04 Day
Date of IRB	2020 Year 12 Month 07 Day
Anticipated trial start date	2020 Year 12 Month 07 Day
Last follow-up date	2020 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2021 Year 04 Month 02 Day
Last modified on	2021 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050017

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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