UMIN-CTR Clinical Trial

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
Email	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
Email	yamasiro@juntendo.ac.jp

Sponsor
Institute	Probiotics Research Laboratory, Juntendo University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027544