UMIN-CTR Clinical Trial

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