UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056231 |
|---|---|
| Receipt number | R000062769 |
| Scientific Title | A multicenter prospective and retrospective study to establish the clinical background of eosinophilic enteritis using a balloon endoscope |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2025/08/21 06:25:31 |
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Basic information
Public title
A multicenter study to establish the clinical background of eosinophilic enteritis using a balloon endoscope
Acronym
Multicenter study of eosinophilic enteritis using balloon endoscope
Scientific Title
A multicenter prospective and retrospective study to establish the clinical background of eosinophilic enteritis using a balloon endoscope
Scientific Title:Acronym
A multicenter study to establish the clinical background of eosinophilic enteritis
Region
| Japan |
Condition
Condition
Eosinophilic enteritis
Classification by specialty
| Medicine in general | Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Eosinophilic enteritis has received much attention in recent years, but its clinical background has not yet been established. Therefore, the purpose of this study is to evaluate the clinical background in the small intestine of patients with suspected eosinophilic enteritis.
Basic objectives2
Others
Basic objectives -Others
Investigate the association with other eosinophilic gastrointestinal and enteritis diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of eosinophil infiltration in the small intestinal mucosa of patients with suspected eosinophilic enteritis
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suspected eosinophilic enteritis of the small bowel who meet the following criteria are eligible for the study.
1) Patients 6 years of age or older who are able to undergo small bowel endoscopy at the time consent is obtained.
2) Patients who have received a full explanation of their participation in this study, and who have given their consent based on full understanding (either from the research subject himself/herself or a proxy).
3) Patients who have undergone small bowel endoscopy and histopathological examination by biopsy at participating hospital in the past.
Key exclusion criteria
1) Patients for whom endoscopic mucosal biopsy is contraindicated
2) Patients with dysfunction of vital organs (heart, lungs, liver, kidney, etc.)
3) Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Shimatani |
Organization
Kansai Medical University Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
06-6992-1001
shimatam@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yamashina |
Organization
Kansai Medical University Medical Center
Division name
Division of Gastroenterology and Hepatology
Zip code
546-0031
Address
10-15 Fumizono-cho, Moriguchi, Osaka
TEL
06-6992-1001
Homepage URL
yamastak@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
he Ethics Committees of Kansai Medical University Medical Center
Address
10-15 Fumizono-cho, Moriguchi, Osaka
Tel
0669921001
rinriirb@hirakata.kmu.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
| 2024 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062769
