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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043823
Receipt No. R000050017
Scientific Title Influence of preservation environments on salivary microbiota profiles in 16S rRNA sequencing
Date of disclosure of the study information 2021/04/02
Last modified on 2021/04/02

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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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