UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007017
Receipt number R000008274
Scientific Title Analysis of mucosal inductive site for the development of digestive diseases
Date of disclosure of the study information 2012/01/05
Last modified on 2019/01/09 13:06:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Analysis of mucosal inductive site for the development of digestive diseases

Acronym

Analysis of mucosal inductive site for the development of digestive diseases

Scientific Title

Analysis of mucosal inductive site for the development of digestive diseases

Scientific Title:Acronym

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

1st name
Middle name
Last name Hideki Iijima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3621

Email

hiijima@gh.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Iijima

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871

TEL

0638793621

Homepage URL


Email

hiijima@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Endoscopic images using magnifying endoscopy revealed apparent alteration in inflammatory bowel disease patients in comparison to healthy subjects.

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

Completed

Date of protocol fixation

2008 Year 10 Month 05 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008274


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name