UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011633
Receipt No. 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 (Ver. 5)

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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
Institute Osaka University Hospital
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013605