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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034021
Receipt No. 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

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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
Email 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
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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