UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007017 |
|---|---|
| Receipt number | R000008274 |
| Scientific Title | Analysis of mucosal inductive site for the development of digestive diseases |
| Date of disclosure of the study information | 2012/01/05 |
| Last modified on | 2019/01/09 13:06:12 |
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Basic information
Public title
Analysis of mucosal inductive site for the development of digestive diseases
Acronym
Analysis of mucosal inductive site for the development of digestive diseases
Scientific Title
Analysis of mucosal inductive site for the development of digestive diseases
Scientific Title:Acronym
Analysis of mucosal inductive site for the development of digestive diseases
Region
| Japan |
Condition
Condition
Patients with inflammatory bowel disease, subjects performed with colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the role of mucosal inductive sites(e.g., Peyer's patches) in patients with digestive diseases (including inflammatory bowel diseases).
Basic objectives2
Others
Basic objectives -Others
Observational study of Peyer's patches
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in histopathologic structures of Peyer's patches.
Key secondary outcomes
Changes in endoscopic images and inhabitant bacteria of Peyer's patches.
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 who perform colonoscopy
Key exclusion criteria
Patients who cannot stop anticoagulant therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
hiijima@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871
TEL
0638793621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Grauadate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 05 | 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
Endoscopic images using magnifying endoscopy revealed apparent alteration in inflammatory bowel disease patients in comparison to healthy subjects.
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
| 2008 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | 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
Patients including inflammatory bowel disease patients required to be examined by colonoscopy are subjected to precise observation with narrow band imaging with magnifying endoscopy of Peyer's patches in the ileum. Peyer's patches are histopathologically investigated and inhabitant bacteria are analyzed.
Management information
Registered date
| 2012 | Year | 01 | Month | 04 | Day |
Last modified on
| 2019 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008274
