UMIN-CTR Clinical Trial

Basic information
Public title	Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Acronym	Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Scientific Title	Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Scientific Title:Acronym	Alterations of gut microbiome and mucosal permeability in inactive IBD patients with IBS-like symptom
Region	Japan

Condition
Condition	inactive IBD patients with IBS-like symptom
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aims of study are to evaluate the alteration of gut microbiome in inactive IBD patients with IBS-like symptom
Basic objectives2	Others
Basic objectives -Others	The aims of study are to evaluate the alteration of mucosal permeability in inactive IBD patients with IBS-like symptom
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gut microbiome
Key secondary outcomes	1.mucosal permeability 2.inflammatory cytokine 3.short chain fatty acid 4.tight junction

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	20 years-old <
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Inactive IBD patients with IBS-like symptom aged 20-75 years and diagnosed according to the Rome III criteria
Key exclusion criteria	Candidates are excluded if any of the following are evident: current evidence of malignant disease or renal dysfuncti or liver dysfunction
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology,Department of Internal Medicine
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL	+81-798-45-6662
Email	miwahgi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Toshihiko Middle name Last name Tomita
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code	663-8501
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
TEL	+81-798-45-6662
Homepage URL
Email	tomita@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo College of Medicine
Address	1-1,Mukogawa-cho,Nisinomiya,Hyogo 663-8501,Japan
Tel	81798456662
Email	tomita@hyo-med.ac.jp

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	兵庫医科大学病院

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 27 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	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 03 Month 22 Day
Anticipated trial start date	2019 Year 03 Month 22 Day
Last follow-up date	2020 Year 08 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 08 Month 27 Day
Last modified on	2020 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046932