UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047375 |
|---|---|
| Receipt number | R000053963 |
| Scientific Title | A study of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease |
| Date of disclosure of the study information | 2022/04/11 |
| Last modified on | 2022/04/03 10:20:17 |
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Basic information
Public title
A study of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease
Acronym
A study of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease
Scientific Title
A study of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease
Scientific Title:Acronym
A study of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease
Region
| Japan |
Condition
Condition
Subjects who underwent a medical checkup and patients with digestive system disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigation of the association between oral microbiota and digestive system diseases
Basic objectives2
Others
Basic objectives -Others
The investigation of the association between various background factors including microbiota and digestive system diseases in subjects with and without metabolic syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of oral microbiota associated with various digestive system diseases
Key secondary outcomes
Investigation of factors associated with various digestive system diseases
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who underwent a medical checkup and subjects with digestive system diseases
Key exclusion criteria
<Subjects who fulfill the exclusion criteria for gastroesophageal reflux disease>
1. Subjects who had a history of digestive tract surgery
2. Subjects visiting the hospital for treatment for intestinal disease including GERD
3. Subjects who are followed up for intestinal disease including GERD
4. Subjects who were diagnosed with upper intestinal cancer at the time of esophagogastroduodenoscopy
5. Subjects who had a malignant tumor
<Subjects who fulfill the exclusion criteria for nonalcoholic fatty liver disease>
1. Subjects who were positive for hepatitis B surface antigen
2. Subjects who were positive for hepatitis C antibody
3. Subjects who had a history of various hepatic disorders
4. Subjects who consumed 20 g/day or more of alcohol
5. Subjects who had a malignant tumor
<Subjects who fulfill the exclusion criteria for various digestive system diseases excluding above mentioned disease>
1. Subjects who had a history of digestive organ surgery
2. Subjects who had a malignant tumor
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Okahisa |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of General Medicine and Community Health Science
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima city
TEL
088-633-7124
okahisa5505@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Sogabe |
Organization
Health Service, Counseling and Accessibility Center, Tokushima University
Division name
Health Service
Zip code
770-8502
Address
1-1 Minamijosanjima-cho, Tokushima city
TEL
088-656-7289
Homepage URL
sogabe.masahiro@tokushima-u.ac.jp
Sponsor or person
Institute
Shikoku Central Hospital of the Mutual aid Association of Public School Teachers
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science and technology-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
not applicable
Address
not applicable
Tel
not applicable
not applicable
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The investigation of the association between oral microbiota and digestive system diseases including gastroesophageal reflux disease in subjects who underwent medical checkup and subjects with digestive system diseases
Management information
Registered date
| 2022 | Year | 04 | Month | 03 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053963
| Research Plan | |
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| Registered date | File name |
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