UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034144 |
|---|---|
| Receipt number | R000038924 |
| Scientific Title | A study for a search of biomarkers of irritable bowel syndrome (multicenter study) |
| Date of disclosure of the study information | 2019/12/31 |
| Last modified on | 2022/12/19 20:10:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for a search of biomarkers of irritable bowel syndrome (multicenter study)
Acronym
A study for a search of biomarkers of irritable bowel syndrome
Scientific Title
A study for a search of biomarkers of irritable bowel syndrome (multicenter study)
Scientific Title:Acronym
A study for a search of biomarkers of irritable bowel syndrome
Region
| Japan |
Condition
Condition
Irritable bowel syndrome
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Searching for biomarkers of irritable bowel syndrome
Basic objectives2
Others
Basic objectives -Others
A search for biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Markers of biological samples
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)IBS patients who are judged as diarrhea type or mix type by Bristol stool scale or healthy people.
(2)Subjects who understood the detail of this study and agreed to attend by signature
Key exclusion criteria
(1)Subjects who have structural disease
(2)Subjects who have immunodeficiency
(3)Subjects who experienced abdominal surgery
(4)Subjects who have infectious disease at respiratory tract or digestive organ or urinary system
(5)Subjects who have sever disease besides described at (1)-(4)
(6)Subjects who are pregnant or lactating period
(7)Subjects who have taken antimicrobial anent within last 3 months
(8)Subjects who are scheduled to take antimicrobial agent within hereafter 2 months
(9)Subjects who refuse to answer sexuality
(10)Subjects who are attending or scheduled to attend the other clinical study
(11)Subjects who are infected or had been infected with HIV, HAV, HBV, HCV or HTLV
(12)Subjects who are judged as unsuitable for participating this study by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Mitsuyama |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942-31-7561
ibd@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Kanayama |
Organization
Kirin company, Limited
Division name
Research Laboratories for Health Science & Food Technologies Research & Development Division
Zip code
2360004
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa Japan
TEL
080-1031-9208
Homepage URL
Masaya_Kanayama@kirin.co.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institutes of Biomedical Innovation, Health and Nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Kurume University
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942-31-7917
i_rinri@kurume-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
柳川病院 (福岡県)
戸畑共立病院 (福岡県)
自衛隊阪神病院 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 31 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In search of biomarkers of IBS, biological samples of healthy subjects and IBS patients are compared.
Management information
Registered date
| 2018 | Year | 09 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038924
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
