UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013578 |
|---|---|
| Receipt number | R000015846 |
| Scientific Title | Study of the Prevalence of celiac disease in Japan. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2018/10/05 14:45:31 |
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Basic information
Public title
Study of the Prevalence of celiac disease in Japan.
Acronym
Prevalence of celiac disease.
Scientific Title
Study of the Prevalence of celiac disease in Japan.
Scientific Title:Acronym
Prevalence of celiac disease.
Region
| Japan |
Condition
Condition
Celiac disease.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to reveal the prevalence of celiac disease in healthy people who have a complete medical check-up.
Basic objectives2
Others
Basic objectives -Others
to reveal the prevalence of celiac disease in patients who have functional chronic abdominal symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anti-tissue transglutaminase IgA antibody.
serum endomysial IgA antibody (EMA).
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy people who visit medical check-up
Patients who complained of abdominal discomfort, as abdominal pain, diarrhea and constipation, with negative endoscopy/radiology test and laboratory data were enrolled.
Key exclusion criteria
nothing
Target sample size
2300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853202190
imaganasu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University School of Medicine
Division name
department of Gastroenterology and Hepatology
Zip code
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Homepage URL
imaganasu@yahoo.co.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine
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
島根大学医学部付属病院（島根県）、島根県環境保険公社総合健診センター（島根県）
松江赤十字病院（島根県）、松江市立病院（島根県）、島根県立中央病院（島根県）
出雲市総合医療センター（島根県）、益田地域医療センター医師会病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2014 | Year | 03 | Month | 31 | Day |
Last modified on
| 2018 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015846
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
