UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057593 |
|---|---|
| Receipt number | R000065800 |
| Scientific Title | Novel Fecal Biomarker for Irritable Bowel Syndrome |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/04/11 18:00:26 |
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Basic information
Public title
Novel Fecal Biomarker for Irritable Bowel Syndrome
Acronym
Novel Fecal Biomarker for Irritable Bowel Syndrome
Scientific Title
Novel Fecal Biomarker for Irritable Bowel Syndrome
Scientific Title:Acronym
Novel Biomarker for IBS
Region
| Japan |
Condition
Condition
Patients with Irritable Bowel Syndrome and Healthy Subjects
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing the composition of membrane vesicles between patients with irritable bowel syndrome and healthy subjects
Basic objectives2
Others
Basic objectives -Others
Comparing the composition of fecal bacterial composition between patients with irritable bowel syndrome and healthy subjects
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hydroxysteroid 11-beta dehydrogenase 2 (HSD11B2) gene expression level in the fecal samples
Key secondary outcomes
Gut microbiome and metabolites in the fecal samples
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
IBS patients: meet Rome IV criteria for IBS and do not meet the exclusion criteria
Healthy subjects: those who do not meet Rome IV criteria and have no other complications
Key exclusion criteria
IBS patients: have histories of abdominal surgeries and/or colorectal diseases other than IBS
Healthy controls: have other serious complications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Motoyori |
| Middle name | |
| Last name | Kanazawa |
Organization
Tohoku University Hospital
Division name
Division of Psychosomatic Medicine
Zip code
980-8574
Address
1-1 Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-7327
motoyori.kanazawa.d4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Motoyori |
| Middle name | |
| Last name | Kanazawa |
Organization
Tohoku University Hospital
Division name
Division of Psychosomatic Medicine
Zip code
980-8574
Address
1-1 Seiryo, Aoba, Sendai, Miyagi
TEL
022-717-7327
Homepage URL
motoyori.kanazawa.d4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo, Aoba, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2025 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fecal HSD11B2 gene expression level and composition of gut microbiome will be compared between patients with irritable bowel syndrome and healthy subjects. This is a case-control study with no intervention.
Management information
Registered date
| 2025 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065800
