UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022674 |
|---|---|
| Receipt number | R000024686 |
| Scientific Title | Study of celiac disease antibodies and IgG4 antibody in inflammatory bowel disease |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2018/12/11 20:31:34 |
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Basic information
Public title
Study of celiac disease antibodies and IgG4 antibody in inflammatory bowel disease
Acronym
Study of celiac disease antibodies and IgG4 antibody in IBD
Scientific Title
Study of celiac disease antibodies and IgG4 antibody in inflammatory bowel disease
Scientific Title:Acronym
Study of celiac disease antibodies and IgG4 antibody in IBD
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to reveal clinical usefulness of celiac anntibodies and IgG4 antibody in inflammatory bowel disease
Basic objectives2
Others
Basic objectives -Others
to reveal clinical usefulness of celiac anntibodies and IgG4 antibody in IBD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anti-gliadin IgG, anti-gliadin IgA,anti-tissue transglutaminase IgG,anti-tissue transglutaminase IgA,anti-deamidated gliadin peptide IgA,anti-deamidated gliadin peptide IgG,IgG4 antibody
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
Patients with Inflammatory bowel disease
Key exclusion criteria
nothing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Ishii |
Organization
Kawasaki Medical School
Division name
Gastroenterology Department of Internal Medicine
Zip code
Address
577, Matsushima, Kurashiki city
TEL
086-462-1111
manabuisii@niji.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Ishii |
Organization
Kawasaki Medical School
Division name
Gastroenterology Department of Internal Medicine
Zip code
Address
577, Matsushima, Kurashiki , Okayama 701-0192, Japan
TEL
086-462-1111
Homepage URL
manabuisii@niji.or.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 06 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2018 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024686
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
