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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016804 |
Receipt No. | 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 |
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 |
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Condition | ||||
Condition | irritable bowel syndrome | |||
Classification by specialty |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)Outpatient suffering from irritable bowel syndrome
2)With informed consent obtained before participation |
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Key exclusion criteria | 1)Subjects who were recognized unsuitable for this study by the investigator
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Saiseikai Yokohamashi Nanbu Hospital |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | n/a |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019505 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |