UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034021 |
|---|---|
| Receipt number | R000038709 |
| Scientific Title | The relationship between pathogenesis of irritable bowel syndrome and microbiome |
| Date of disclosure of the study information | 2018/09/13 |
| Last modified on | 2018/09/13 17:17:21 |
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Basic information
Public title
The relationship between pathogenesis of irritable bowel syndrome and microbiome
Acronym
irritable bowel syndrome and microbiome
Scientific Title
The relationship between pathogenesis of irritable bowel syndrome and microbiome
Scientific Title:Acronym
irritable bowel syndrome and microbiome
Region
| Japan |
Condition
Condition
irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare microbiome between patients with irritable bowel syndrome and healthy controls. To investigate relationships between microbiome and symptoms or QOL scores of patients with IBS.
Basic objectives2
Others
Basic objectives -Others
To compare prevalence of food hypersensitibity or serum cytokine profile between patients with irritable bowel syndrome and healthy controls.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of microbiome
Key secondary outcomes
Prevalence of food hypersensitivity.
Serum cytokine profile
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with irritable bowel syndrome. Healthy controls.
Key exclusion criteria
Patients with systemic inflanmatoris disease. Patients with malignant disorders.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsusima, Kurashiki city, Okayama, Japan
TEL
086-462-1111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Self sustaining
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
川崎医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 13 | 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
| 2018 | Year | 09 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038709
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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