UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011633
Receipt number R000013605
Scientific Title Morphological and functional analysis of Peyer's patches in inflammatory bowel disease patients by narrow band magnifying enteroscopy
Date of disclosure of the study information 2013/09/02
Last modified on 2019/09/07 23:24:05

* 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

Morphological and functional analysis of Peyer's patches in inflammatory bowel disease patients by narrow band magnifying enteroscopy

Acronym

Analysis of Peyer's patches in inflammatory bowel disease patients by narrow band magnifying enteroscopy

Scientific Title

Morphological and functional analysis of Peyer's patches in inflammatory bowel disease patients by narrow band magnifying enteroscopy

Scientific Title:Acronym

Analysis of Peyer's patches in inflammatory bowel disease patients by narrow band magnifying enteroscopy

Region

Japan


Condition

Condition

Patients with inflammatory bowel diseases and patients who are examined by colonoscopy

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the morphologica and functional changes of Peyer's patches in inflammatory bowel diseases examined by narrow band magnifying enteroscopy.

Basic objectives2

Others

Basic objectives -Others

To clarify the relationship between morphological changes of Peyer's patches and their inhabitant bacteria.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between the changes of Peyer's patches and clinical course of inflammatory bowel disease

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

Patients who are examined by ileocolonoscopy for the investigation of suspicious ileal or colonic diseases.

Key exclusion criteria

1) Patients who were resected ileocecal valve.
2) Patients who take NSAIDs
3) Patients with history of tuberculosis
4) Patients with Behcet disease
5) Patients who were diagnosed as chronic intestinal diseases other than Crohn's disease and ulcerative colitis.
6) Patients with cancer
7) Patients who are undergoing total parental nutrition therapy
8) Patients with severe malnutrition
9) Patients who are not suitable for attending the study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hideki
Middle name
Last name Iijima

Organization

Osaka University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-15 Yamadaoka, Suita, Osaka

TEL

06-6879-3621

Email

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


Public contact

Name of contact person

1st name Hideki
Middle name
Last name IIjima

Organization

Osaka University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-15 Yamadaoka, Suita, Osaka

TEL

06-6879-3621

Homepage URL


Email

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


Sponsor or person

Institute

Osaka University Hospital

Institute

Department

Personal name



Funding Source

Organization

Osaka 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

Osaka University Hospital

Address

2-15 Yamadaoka, Suita, Osaka

Tel

06-6879-5500

Email

rinri@hp-crc.med.osaka-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

2013 Year 09 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://irjournal.org/journal/view.php?doi=10.5217/ir.2016.14.4.314

Number of participants that the trial has enrolled

67

Results

We collected NBI-ME images of PPs from 67 UC patients. The patients were divided into two groups on the basis of villi index: low (L)- and high (H)-types. The time to clinical recurrence was significantly shorter in remissive UC patients with H-type PPs than in those with L-type PPs. Multivariate analysis revealed that the existence of H-type PPs was an independent risk factor for clinical recurrence.

Results date posted

2019 Year 09 Month 07 Day

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

2013 Year 08 Month 15 Day

Date of IRB

2013 Year 08 Month 15 Day

Anticipated trial start date

2013 Year 09 Month 01 Day

Last follow-up date

2019 Year 05 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

NA


Management information

Registered date

2013 Year 09 Month 02 Day

Last modified on

2019 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013605


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name