UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1 expression between Korea and Japan
Title of the study (Brief title)	Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1
Region	Japan Asia(except Japan)

Condition
Condition	Functional dyspepsia
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Functional dyspepsia(FD) is defined as upper gastro-intestinal disease whose patients complain such as epigastric pain and discomfort without any structual, systemic, metabolic diseases as cause of the symptom. Although the pathogenesis of FD is still unknown, relationship between gastrointestinal infection and occurance of FD is recently supposed in some patients with FD. Some researches report that transient receptor potential ion channel of the vanilloid type 1 (TRPV1), one of the receptor of capsaicin, is related to gastrointestinal sensation. Also, gene polymorphism, especially 315C, might be associated with susceptibility of FD occurance. However, detailed pathogenesis including molecular mechanism, genetic factors, differences of race and food habit, is still unclear. Now we focus on the relationship among duodenal inflammation, expression or polymorphism of TRPV1, and severity of FD symptom. Also, through collaboration with Korean research group, we analyze differences of race, food habit, infection rate of H.pylori on FD between Japan and Korea, and then we aim to find out pathogenesis and create new therapy of FD.
Basic objectives2	Others
Basic objectives -Others	To analyze difference of impact by race, food habit, infection rate of H.pylori on FD symptom between Japan and Korea
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	PAGI-SYM
Key secondary outcomes	Dyspepsia-related score GERDQ HADS PAGI-QOL Life-style Food-life TRPV1 expression in duodenum TRPV1 polymorphism

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	Patients whose symptoms fullfill Rome III criteria as shown below. One or more of the following: a. Bothersome postprandial fullness b. Early satiation c. Epigastric pain d. Epigastric burning AND No evidence of structural disease(including at upper endoscopy) that is likely to explain the symptoms * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Key exclusion criteria	1. Patients who have structural disease including erosive gastritis and GERD. 2. Patients who have history of upper GI operation 3. Patients whose causes of dyspepsia are obvious like taking much food, drink, NSAIDs, much stress, and so on. 4. Patients who have history of brain structual disease, schizophrenia, and depression. 5. Alcohol or drug dependent patients. 6. Patients who have severe disorder of endocrine system like hyperthyroidism. 7. Patients who have severe disorder of cardiovascular system, liver system, renal function, infection, and hematopoietic organ. 8. Patients who have allergic reaction for some drugs for gastrointestinal system. 9. Pregnancy or lactation woman. Patients who hope pregnancy during study. 10. Patients who took H. pylori eradication therapy within 6 months 11. Patients who are difficult to stop taking drugs like gastrointestinal drugs, anti-choline drugs, anti-depressant, and so on. 12. Suspitious for IBS 13. Any other patients which primary doctor judges them appropriate for this study.
Target sample size	200

Research contact person
Name of lead principal investigator	Hidekazu Suzuki
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Gastroenterology and hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3914
Email	hsuzuki@a6.keio.jp

Public contact
Name of contact person	Hidekazu Suzuki
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Gastroenterology and hepatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3914
Homepage URL
Email	hsuzuki@a6.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Non profit foundation
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	2012 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 26 Day
Anticipated trial start date	2012 Year 12 Month 31 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	Published
URL releasing results
Results	Upper gastrointestinal symptoms are more common in subjects with a higher consumption of spicy foods, younger age and female gender, regardless of TRPV1 genotypes and the H. pylori infection status.
Other related information	Patient who have symptom like postprandial fullness, early satiation, , epigastric pain, and epigastric burning which occur at least 6 month before and consist at least 3 moth before visit. Also, there is no structural diseases in gastrointestinal tract. We examine severity of symptoms by questionnaires, H. pylori infection by gastric biopsy, and TRPV1 expression or polymorphism by duodenal biopsy and blood exam.

Management information
Registered date	2012 Year 12 Month 31 Day
Last modified on	2017 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011274