UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007385
Receipt number R000008636
Scientific Title Comparative study on duodenal sensory receptor function in patients with functional dyspepsia between Belgium and Japan
Date of disclosure of the study information 2012/03/01
Last modified on 2016/08/31 17:38:26

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Basic information

Public title

Comparative study on duodenal sensory receptor function in patients with functional dyspepsia between Belgium and Japan

Acronym

Duodenal sensory receptor function in patients with functional dyspepsia

Scientific Title

Comparative study on duodenal sensory receptor function in patients with functional dyspepsia between Belgium and Japan

Scientific Title:Acronym

Duodenal sensory receptor function in patients with functional dyspepsia

Region

Japan Europe


Condition

Condition

Functional dyspepsia

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine

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 Belgium research group, we analyze differences of race, food habit, infection rate of H.pylori on FD between Japan and Belgium, and then we aim to find out pathogenesis and create new therapy of FD.

Basic objectives2

Others

Basic objectives -Others

To analyze differences of race, food habit, infection rate of H.pylori on FD between Japan and Belgium

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


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

100


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

81-3-5363-3914

Email

hsuzuki@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

81-3-5363-3914

Homepage URL


Email

hsuzuki@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


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 03 Month 01 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

Completed

Date of protocol fixation

2012 Year 01 Month 24 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2013 Year 03 Month 01 Day

Date of closure to data entry

2013 Year 04 Month 01 Day

Date trial data considered complete

2013 Year 04 Month 01 Day

Date analysis concluded

2013 Year 06 Month 01 Day


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 02 Month 27 Day

Last modified on

2016 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name