UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061912 |
|---|---|
| Receipt number | R000070810 |
| Scientific Title | A multicenter prospective observational study to evaluate fecal eosinophil-derived neurotoxin (EDN) for predicting treatment response and selecting biologic agents in inflammatory bowel disease |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/15 14:55:29 |
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Basic information
Public title
Study on prediction of treatment response using fecal EDN in patients with inflammatory bowel disease
Acronym
EDN biomarker study in IBD
Scientific Title
A multicenter prospective observational study to evaluate fecal eosinophil-derived neurotoxin (EDN) for predicting treatment response and selecting biologic agents in inflammatory bowel disease
Scientific Title:Acronym
IBD-EDN prospective multicenter study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease (ulcerative colitis, Crohn's disease)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate whether serum and fecal eosinophil-derived neurotoxin (EDN), as well as the EDN/fecal calprotectin ratio, reflect disease activity, endoscopic activity, inflammatory phenotypes, and treatment response to biologics or small-molecule therapies in patients with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
Exploratory evaluation of the clinical utility of EDN-related biomarkers and their predictive performance for treatment response.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between baseline fecal EDN levels and the EDN/fecal calprotectin ratio and clinical disease activity indices in ulcerative colitis or Crohn's disease.
Key secondary outcomes
Associations of fecal EDN levels and the EDN/fecal calprotectin ratio with endoscopic activity; predictive performance of EDN-related markers before initiation of biologics or small-molecule therapy; longitudinal changes in EDN-related markers at approximately 16 and 52 weeks after treatment initiation and their association with clinical remission and relapse; additive value over existing biomarkers; and associations with mucosal cytokine profiles in a subset of patients.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ulcerative colitis or Crohn's disease; patients for whom clinical disease activity assessment, stool sampling, and endoscopic evaluation as needed are feasible during routine clinical practice; patients who provide written informed consent; and patients scheduled for initiation or switching of biologics or small-molecule therapy may be included.
Key exclusion criteria
Patients considered unsuitable for participation by the principal investigator or co-investigators; patients from whom adequate consent cannot be obtained; patients for whom sample collection or clinical data acquisition is difficult; and patients meeting any other exclusion criteria defined in the protocol.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Mishima |
Organization
Shimane University Faculty of Medicine
Division name
Second Department of Internal Medicine
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
mtmtyui@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Mishima |
Organization
Shimane University Faculty of Medicine
Division name
Second Department of Internal Medicine
Zip code
6930021
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL
0853-20-2190
Homepage URL
mtmtyui@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Gastroenterology Clinical Research Grant (applied). JSPS KAKENHI Grant-in-Aid for Scientific Research (C) and a research grant from the JSIBD.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Shimane University Faculty of Medicine. The official name
Address
89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2026 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective observational study with no intervention. Fecal EDN levels, clinical indices, laboratory data, endoscopic findings, reasons for selecting biologics, and treatment outcomes will be collected during routine clinical practice. These observational data will be analyzed to evaluate the association between fecal EDN and both biologic selection and treatment response.
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070810
