UMIN-CTR Clinical Trial

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
Email	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
Email	sogabe.masahiro@tokushima-u.ac.jp

Sponsor
Institute	Shikoku Central Hospital of the Mutual aid Association of Public School Teachers
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053963