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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009673
Receipt No. R000011274
Scientific Title Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1 expression between Korea and Japan
Date of disclosure of the study information 2012/12/31
Last modified on 2017/03/13

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Basic information
Public title Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1 expression between Korea and Japan
Acronym Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1
Scientific Title Comparative study on dyspeptic symptom generation and gastroduodenal capsaicin/TRPV1 expression between Korea and Japan
Scientific Title:Acronym 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
1st name
Middle name
Last name Hidekazu Suzuki
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Gastroenterology and hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3914
Email hsuzuki@a6.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Suzuki
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Gastroenterology and hepatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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