UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016804 |
|---|---|
| Receipt number | R000019505 |
| Scientific Title | An epidemiologic study of irritable bowel syndrome; multicenter study in Japan |
| Date of disclosure of the study information | 2015/03/15 |
| Last modified on | 2017/03/21 21:31:44 |
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Basic information
Public title
An epidemiologic study of irritable bowel syndrome; multicenter study in Japan
Acronym
An epidemiologic study of IBS
Scientific Title
An epidemiologic study of irritable bowel syndrome; multicenter study in Japan
Scientific Title:Acronym
An epidemiologic study of IBS
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the patient's background of IBS
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to clarify the clinical features of IBS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of this study is to clarify the patient's background of IBS
Key secondary outcomes
To evaluate as follows;
1)Risk factor for severe IBS
2)Gender difference of IBS
3)Therapeutic course of IBS
4)Association between menstrual cramps and IBS
5)Association between pregnancy, parturition and IBS
6)Influence of proton pump inhibitor to IBS
7)Consultation rate of endoscopy in IBS patient
8)Association between obesity and IBS
9)Comparison of the clinical features of patient with IBS in clinic and flagship hospital
10)Association between subtype of IBS and QOL
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
| 15 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Outpatient suffering from irritable bowel syndrome
2)With informed consent obtained before participation
Key exclusion criteria
1)Subjects who were recognized unsuitable for this study by the investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
yamadae@nanbu.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yamada |
Organization
Saiseikai Yokohamashi Nanbu Hospital
Division name
Gastroenterology
Zip code
Address
3-2-10 Kounandai Kounan-ku, Yokohama City, Kanagawa, Japan
TEL
045-832-1111
Homepage URL
yamadae@nanbu.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai Yokohamashi Nanbu Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Yokohamashi Nanbu Hospital
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
Address
Tel
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
| 2015 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27129979
Number of participants that the trial has enrolled
Results
Lower MCS and female sex were risk factors for poor therapeutic response in patients with IBS.
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
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 01 | Day |
Other
Other related information
n/a
Management information
Registered date
| 2015 | Year | 03 | Month | 15 | Day |
Last modified on
| 2017 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019505
