UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046082 |
|---|---|
| Receipt number | R000052604 |
| Scientific Title | Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model |
| Date of disclosure of the study information | 2021/11/17 |
| Last modified on | 2021/11/16 16:13:46 |
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Basic information
Public title
Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Acronym
Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Scientific Title
Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Scientific Title:Acronym
Examination of the role of lymphocytes in intestinal mucosal permeability using intestinal epithelial permeability control model
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between intestinal permeability and lymphocytes.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in interepithelial electrical resistance
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient's written consent to participate in the research must be obtained.
Eligible patients must be diagnosed with ulcerative colitis or Crohn's disease.
The healthy control is a faculty member of Shimane University School of Medicine and has not been diagnosed with either ulcerative colitis or Crohn's disease.
Key exclusion criteria
Healthy controls are those with abnormal findings on gastrointestinal endoscopy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kishimoto |
Organization
Shimane University, Faculty of Medicine
Division name
Internal Medicine II
Zip code
693-8501
Address
89-1, Enya-tyo, Izumo city, Shimane prefecture
TEL
0853-20-2190
kk0901@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Kishimoto |
Organization
Shimane University, Faculty of Medicine
Division name
Internal Medicine II
Zip code
693-8501
Address
89-1, Enya-tyo, Izumo city, Shimane prefecture
TEL
0853-20-2190
Homepage URL
kk0901@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Shimane University, Faculty of Medicine
Address
89-1, Enya-tyo, Izumo city, Shimane prefecture
Tel
0853202111
kk0901@med.shimane-u.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
| 2021 | Year | 11 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | 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
Comparison of intestinal permeability of each lymphocyte
Management information
Registered date
| 2021 | Year | 11 | Month | 16 | Day |
Last modified on
| 2021 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052604
