UMIN-CTR Clinical Trial

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
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Interventions/Control_5
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Interventions/Control_7
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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
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IRB Contact (For public release)
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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
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
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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
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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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