UMIN-CTR Clinical Trial

Basic information
Public title	Association between inflammatory bowel disease and cellular stress response
Acronym	IBD and celluar stress response
Scientific Title	Association between inflammatory bowel disease and cellular stress response
Scientific Title:Acronym	IBD and celluar stress response
Region	Japan

Condition
Condition	Inflammatory bowel disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the association between inflammatory bowel disease and cellular stress response
Basic objectives2	Others
Basic objectives -Others	To assess pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The assciation betwen activity of inflammatory bowel disease and cellular stress response
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	Divided into groups by clinical diagnoses
Interventions/Control_2	Biopsies during colonoscopy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who underwent colonoscopy within 3 years 2. Patients who are going to undergo colonoscopy 3. Patients with inflammatory bowel disease (Ulcerative colitis or Crohn's disease) or patients who undergo colonoscopy
Key exclusion criteria	1.Biopsy cannnot be performed 2.Colonoscopy cannot be performed (shown below) a. patients with difficulty of colonoscopy b. patients with active bleeding c. patients with instability of circulation and breathing d. patients who cannot take bowel preparation
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-19-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Email	shikokuri@gunma-u.ac.jp

Public contact
Name of contact person	1st name Shiko Middle name Last name Kuribayashi
Organization	Gunma University Hospital
Division name	Department of Gastroenterology and Hepatology
Zip code	371-8511
Address	3-19-15 Showa-machi, Maebashi, Gunma, Japan
TEL	027-220-8137
Homepage URL
Email	shikokuri@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

Funding Source
Organization	Gunma University Hospital
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	Gunma University Hospital Institutional Review Board
Address	3-39-15 Showa-machi Maebashi, Gunma, Japan
Tel	027-220-8740
Email	shikokuri@gunma-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	2016 Year 02 Month 25 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	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 17 Day
Date of IRB	2015 Year 11 Month 26 Day
Anticipated trial start date	2016 Year 01 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2022 Year 05 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023180