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 |
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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
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
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
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
