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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028098
Receipt No. R000031305
Scientific Title Fundamental study in the correlation of sleep bruxism and stomach flora
Date of disclosure of the study information 2017/08/01
Last modified on 2018/01/09

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Basic information
Public title Fundamental study in the correlation of sleep bruxism and stomach flora
Acronym Fundamental study in the correlation of sleep bruxism and stomach flora
Scientific Title Fundamental study in the correlation of sleep bruxism and stomach flora
Scientific Title:Acronym Fundamental study in the correlation of sleep bruxism and stomach flora
Region
Japan

Condition
Condition Peptic ulcer, atrophic gastritis, malignant lymphoma, early stomach cancer
Classification by specialty
Gastroenterology Laboratory medicine Dental medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between stomach flora around H. pylori and stomach disease.
Basic objectives2 Others
Basic objectives -Others The relationship between stomach flora and stomach diseases
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire
Intraoral examination
Urea breath test
Metagenome analysis of the stomach flora
Key secondary outcomes Sleep bruxism
Metagenome analysis of the oral flora

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. Peptic ulcer, atrophic gastritis, Malignant lymphoma, early stomach cancer
2. Patients eligible for an outpatient test
3. Patients accepting of an endoscopic examination
Key exclusion criteria 1. Patients taking medication for neurologic disorders and psychiatric disorders within the previous 3 month
2. Patients taking the drug of PPI within the previous a month.
3. Patients receiving Gastrectomy
4. Patients with serious complication (kidney disorder and impaired hepatic function)
5. Patients taking administration of an antimicrobial agent in an endoscopic examination
6. Patients with test drug allergies of urea breath test
7. Patients with pregnancy, postpartum within 28th day or during lactation
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takakazu Yagi
Organization Kagoshima university hospital
Division name Orthdontics
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima
TEL +81-99-275-6252
Email tyagi@dent.kagoshima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takakazu Yagi
Organization Kagoshima university hospital
Division name Orthdontics
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima
TEL +81-99-275-6252
Homepage URL
Email tyagi@dent.kagoshima-u.ac.jp

Sponsor
Institute Department of Orthodontics, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science, MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
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 鹿児島大学病院(鹿児島県)/ Kagoshima university hospital

Other administrative information
Date of disclosure of the study information
2017 Year 08 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
2017 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Case-control study
Method for collecting participants: public
Subjects: the patients with the subjective symptoms of peptic ulcer, atrophic gastritis, malignant lymphoma and early stomach cancer
Period of collecting participants: From June 2017 to May 2022
Examination item: Questionnaire, Intraoral examination, urea breath test, endoscopic examination system, metagenome analysis

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031305

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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