UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048197 |
|---|---|
| Receipt number | R000054928 |
| Scientific Title | Study of the Prevalence of celiac disease in Asian countries |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2025/10/10 10:53:46 |
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Basic information
Public title
Study of the Prevalence of celiac disease in Asian countries
Acronym
Study of the Prevalence of celiac disease in Asian countries
Scientific Title
Study of the Prevalence of celiac disease in Asian countries
Scientific Title:Acronym
Study of the Prevalence of celiac disease in Asian countries
Region
| Japan |
Condition
Condition
Celiac disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the prevalence of celiac disease in Asian countries.
Basic objectives2
Others
Basic objectives -Others
To study HLA in the patients who are seropositive of Celiac disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the prevalence of seropositive Celiac disease in patients with IBS.
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
patienst with IBS
Key exclusion criteria
DM, IBD, pregnant women, post-surgery
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Higashiyama |
Organization
National Defense Medical College
Division name
department of internal medicine
Zip code
359-8513
Address
National Defense Medical College
TEL
0429951609
cln311@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
department of internal medicine
Zip code
359-8513
Address
3-2 Namiki tokorozawa
TEL
0429951609
Homepage URL
ryota@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College
Address
National Defense Medical College
Tel
0429951609
ins010@ndmc.ac.jp
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
| 2022 | Year | 06 | Month | 30 | 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
600
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
preparing the submission
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-center study
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054928
