UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cross sectional research to elucidate impact of dietary habits on gastric microbiota and serum hormone.
Title of the study (Brief title)	Relationship among dietary habits, gastric microbiota and serum hormone.
Region	Japan

Condition
Condition	Patients who receive upper gastrointestinal endoscopy
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between dietary habits and gastric microbiota.
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between dietary habits and serum hormone.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between dietary habits and gastric microbiota. Association between dietary habits and serum hormone.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	15 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who receive upper gastrointestinal endoscopy
Key exclusion criteria	Patients who take anticoagulants or antiplatelet drug. Patients with eating disorder.
Target sample size	100

Research contact person
Name of lead principal investigator	Akiko Shiotani
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama
TEL	086-462-1111
Email	shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Ryo Katsumata
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsushima, Kurashiki city, Okayama
TEL	086-462-1111
Homepage URL
Email	katsumata@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Self-sustaining fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2019 Year 02 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We elucidate impact of dietary habits on gastric microbiota and serum hormone.

Management information
Registered date	2019 Year 01 Month 28 Day
Last modified on	2019 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040666