UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061836 |
|---|---|
| Receipt number | R000070584 |
| Scientific Title | Evaluation of the Utility of Urinary PGE-MUM in Inflammatory Bowel Disease: A Multicenter Prospective Study |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/08 22:19:47 |
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Basic information
Public title
Evaluation of the Utility of Urinary PGE-MUM in Inflammatory Bowel Disease: A Multicenter Prospective Study
Acronym
Evaluation of the Utility of Urinary PGE-MUM in Inflammatory Bowel Disease: A Multicenter Prospective Study
Scientific Title
Evaluation of the Utility of Urinary PGE-MUM in Inflammatory Bowel Disease: A Multicenter Prospective Study
Scientific Title:Acronym
Evaluation of the Utility of Urinary PGE-MUM in Inflammatory Bowel Disease: A Multicenter Prospective Study
Region
| Japan |
Condition
Condition
Ulcerative colitis, Crohn's disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of urinary PGE-MUM as a biomarker for disease activity and prediction of therapeutic outcomes in patients with ulcerative colitis and Crohn's disease.
Basic objectives2
Others
Basic objectives -Others
From the date of approval by the head of the research institution to March 31, 2028, UC or CD patients receiving outpatient or inpatient care at Okayama University Hospital or participating institutions who newly start or change treatment with 5-ASA, corticosteroids, molecular-targeted agents, small-molecule drugs, tacrolimus, immunomodulators, or blood purification therapy will be enrolled. Urinary PGE-MUM will be measured together with routine blood, stool, and urine tests performed in standard clinical practice. The associations of urinary PGE-MUM with disease activity and serum or fecal biomarkers will be evaluated. Longitudinal associations between changes in disease activity and changes in biomarkers, including urinary PGE-MUM, will also be examined.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
prediction of clinical outcomes, including treatment response
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with inflammatory bowel disease who are receiving outpatient or inpatient care at Okayama University Hospital or participating research institutions
Key exclusion criteria
1.Patients without a confirmed diagnosis
2.Patients with ulcerative colitis who have undergone total colectomy
3.Patients with active malignancy
4.Pregnant or breastfeeding patients
5.Patients who have not provided consent to participate in this study
6.Patients deemed unsuitable for participation by the principal investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Toshihiro |
| Middle name | |
| Last name | Inokuchi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama, Japan
TEL
0862357219
yublue.med@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Aoyama |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
TEL
0862357219
Homepage URL
yublue.med@gmail.com
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi
Tel
0862357219
yublue.med@gmail.com
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 | 03 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The participant has been followed without any related adverse events or events that would warrant discontinuation from the study.
Management information
Registered date
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070584
