UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of mucosal inductive site for the development of digestive diseases
Title of the study (Brief title)	Analysis of mucosal inductive site for the development of digestive diseases
Region	Japan

Condition
Condition	Patients with inflammatory bowel disease, subjects performed with colonoscopy
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the role of mucosal inductive sites(e.g., Peyer's patches) in patients with digestive diseases (including inflammatory bowel diseases).
Basic objectives2	Others
Basic objectives -Others	Observational study of Peyer's patches
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in histopathologic structures of Peyer's patches.
Key secondary outcomes	Changes in endoscopic images and inhabitant bacteria of Peyer's patches.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who perform colonoscopy
Key exclusion criteria	Patients who cannot stop anticoagulant therapy
Target sample size	50

Research contact person
Name of lead principal investigator	Hideki Iijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3621
Email	hiijima@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Hideki Iijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871
TEL	0638793621
Homepage URL
Email	hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Grauadate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 10 Month 05 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Endoscopic images using magnifying endoscopy revealed apparent alteration in inflammatory bowel disease patients in comparison to healthy subjects.
Other related information	Patients including inflammatory bowel disease patients required to be examined by colonoscopy are subjected to precise observation with narrow band imaging with magnifying endoscopy of Peyer's patches in the ileum. Peyer's patches are histopathologically investigated and inhabitant bacteria are analyzed.

Management information
Registered date	2012 Year 01 Month 04 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008274