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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042399
Receipt No. 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

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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
Email 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
Email n-kei@med.kyushu-u.ac.jp

Sponsor
Institute kyushu university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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