UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028098 |
|---|---|
| Receipt number | 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 | 2023/05/26 16:04:03 |
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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
Name of lead principal investigator
| 1st name | Takakazu |
| Middle name | |
| Last name | Yagi |
Organization
Kagoshima university hospital
Division name
Orthdontics
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
+81-99-275-6252
t-yagi@kobe-tokiwa.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Watanabe |
Organization
Kagoshima university hospital
Division name
Orthdontics
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima
TEL
+81-99-275-6252
Homepage URL
a-wtnb@d1.dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of Orthodontics, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
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
Kagoshima university, ethical committee on epidemiological studies
Address
8-35-1, Sakuragaoka, Kagoshima
Tel
+81-99-275-6624
crmc@m2.kufm.kagoshima-u.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
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
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
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
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031305
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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