UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009673 |
|---|---|
| Receipt number | 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 17:15:40 |
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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
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
hsuzuki@a6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011274
