UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043823 |
|---|---|
| Receipt number | 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 | 2023/01/04 11:17:28 |
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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
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
ms04furuhashi@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
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
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
None
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/eos.12852
Number of participants that the trial has enrolled
5
Results
An almost perfect correlation was shown between the immediate extraction and the -15 degree storage group for relative abundance at the genus and operational taxonomic unit levels. The intraindividual UniFrac distances among storage methods were significantly shorter than those of interindividual distances. None of the amount of extracted DNA, the alfa-diversity indices, or the relative abundance at the phylum/genus/operational taxonomic unit level differed among storage methods.
Results date posted
| 2023 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
5 healthy subjects
Participant flow
We performed an observational study to assess the robustness of microbiota profiles in three different storage environments (-80 degree after flash-freezing, -80 degree, and -15 degree; all for 14 days) compared to immediate DNA extraction using the MiSeq Illumina platform
Adverse events
None
Outcome measures
Relative abundance at the genus and OTU level
Amount of observed DNA
alfa-diversity indices
UniFrac distance and PCoA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050017
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
