UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042399 |
|---|---|
| Receipt number | R000048399 |
| Scientific Title | The analysis of intestinal mucosal barrier of the inflammatory bowel disease. |
| Date of disclosure of the study information | 2020/11/09 |
| Last modified on | 2020/11/09 20:04:09 |
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Basic information
Public title
The analysis of intestinal mucosal barrier of the inflammatory bowel disease.
Acronym
The analysis of intestinal mucosal barrier of the inflammatory bowel disease.
Scientific Title
The analysis of intestinal mucosal barrier of the inflammatory bowel disease.
Scientific Title:Acronym
The analysis of intestinal mucosal barrier of the inflammatory bowel disease.
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how the electrical impedance of the gastrointestinal mucosa is involved in inflammatory bowel disease and to help elucidate the pathogenesis of the disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine if there is any change in mucosal impedance values during IBD remission compared to control patients.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients diagnosed with IBD and undergoing total colonoscopy.
(2) Patients who fully understand the study plan and are able to give their consent.
(3) Patient who are older than 20 years old at the time of obtaining consent or Patients who are older than 16 years old of age at the time of obtaining the consent of their parents or guardians.
Key exclusion criteria
(1) Patients for whom total colonoscopy is usually contraindicated (e.g., patients with ileus, gastrointestinal perforation, severe respiratory and cardiovascular diseases).
(2) Patients with poor general condition (e.g., PS level 3 or higher).
(3) Patients for whom informed consent cannot be obtained.
(4) Patients who are deemed by the researcher to be unsuitable as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ogawa |
Organization
Kyushu university
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425082
yogawa@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Nishioka |
Organization
Kyushu university
Division name
Department of Medicine and Bioregulatory Science
Zip code
851-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
0926425082
Homepage URL
n-kei@med.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university
Institute
Department
Personal name
Funding Source
Organization
Kyushu 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
Kyushu university
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
Tel
0926425082
byskenkyu@jimu.kyushu-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
| 2020 | Year | 11 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluate the status of the mucosa for observational studies.
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048399
| 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 |
