UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023920 |
|---|---|
| Receipt number | R000027544 |
| Scientific Title | Characteristics of gut microbiota and systemic complications in patients with periodontal disease |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2020/03/01 10:36:54 |
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Basic information
Public title
Characteristics of gut microbiota and systemic complications in patients with periodontal disease
Acronym
Gut microbiota and systemic complications in periodontal disease
Scientific Title
Characteristics of gut microbiota and systemic complications in patients with periodontal disease
Scientific Title:Acronym
Gut microbiota and systemic complications in periodontal disease
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Association between severity of periodontal disease and gut microbiota composition
Basic objectives2
Others
Basic objectives -Others
Association between severity of periodontal disease and the systemic complications
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between severity of periodontal disease and gut microbiota composition
Key secondary outcomes
Association between severity of periodontal disease and the systemic complications
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
1) Patients who visit outpatient clinic of periodontal disease
Key exclusion criteria
1) Oral mucosal disease or oral cancer
2) Systemic inflammatory disease
3) Hepatic virus infection
4) Metallic implants
5) Pregnant or breast feeding
6) Use of antibiotics within 3 months
7) Collagen disease
8) Intake of Lactobacillus preparation within 2 weeks
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Probiotics Research Laboratory
Zip code
Address
2-1-1 Hongo, Bukyo-ku
TEL
03-3813-3111
yamasiro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Yamashiro |
Organization
Juntendo University Graduate School of Medicine
Division name
Probiotics Research Laboratory
Zip code
Address
2-1-1 Hongo, Bukyo-ku
TEL
03-3813-3111
Homepage URL
yamasiro@juntendo.ac.jp
Sponsor or person
Institute
Probiotics Research Laboratory, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yakult Central Institute
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
Address
Tel
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
順天堂大学医学部付属順天堂医院（東京都）、東京医科歯科大学歯学部付属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2016 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | 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=R000027544
