UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043491 |
|---|---|
| Receipt number | R000049592 |
| Scientific Title | Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/03/01 19:16:05 |
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Basic information
Public title
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Acronym
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Scientific Title
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Scientific Title:Acronym
Investigation of sample collection method for determination of Fusobacterium nucleatum in oral cavity
Region
| Japan |
Condition
Condition
Not applicable (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a sample collection method for quantitative evaluation of the abundance of Fusobacterium nucleatum in the oral cavity of healthy subjects.
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantification of the number of Fusobacterium nucleatum and Fusobacterium spp. in oral specimens.
Quantitative evaluation focusing on a specific strain.
Key secondary outcomes
Detection and quantification of pathogenic genes of Fusobacterium nucleatum.
16S rRNA gene-based or shotgun metagenome analysis.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1. Subjects who have participated in other clinical trials requiring oral health care within 3 months prior to obtaining consent or are currently participating in other clinical trials.
2. Subjects with dentures (including implants) or undergoing orthodontic treatment.
3. Subjects who consumed antibiotics during last 3 months.
4. Subjects with serious or progressive diseases or conditions.
5. Subjects who are currently visiting a dentist or receiving treatment within 3 months prior to obtaining consent (any treatment related to teeth or gums).
6. Subjects who have been determined ineligible by principal investigator or study administrator.
7. Subjects who routinely consume medicines, health foods, supplements, food for specified health uses, or functional foods that affect the oral environment.
8. Subjects with a current or previous food or drug allergy.
9. Smoker
10. Subjects who have excessive drinking habits.
11. Subjects who are currently pregnant or breastfeeding, or who wish to become pregnant during the study period.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Mitsuharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyodo Milk Industry Co. Ltd.
Division name
Research Laboratories
Zip code
190-0182
Address
20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo
TEL
042-597-5911
m-matumoto@meito.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yuzawa |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
n-yuzawa@imeqrd.co.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iryouhoujinsyadan Hakusuikai, Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel
03-6704-5968
n-yuzawa@imeqrd.co.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
協同乳業株式会社研究所
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 01 | 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
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Research
Subject Recruitment: Subjects who meet the selection criteria and do not meet the exclusion criteria will be selected from healthy adult volunteers.
Main items to be measured: The number of Fusobacterium nucleatum in oral specimens.
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049592
| 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 |
