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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000038461
Receipt No. R000043830
Scientific Title Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study)
Date of disclosure of the study information 2019/11/01
Last modified on 2019/11/01

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Basic information
Public title Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phase I, II study)
Acronym A novel evaluation method for intestinal permeability
Scientific Title Investigation of intestinal permeability in inflammatory bowel disease using a novel evaluation method (Phas I, II study)
Scientific Title:Acronym A novel evaluation method for intestinal permeability
Region
Japan

Condition
Condition Inflammatory bowel disease (IBD)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate intestinal permeability for IBD patients and clarify its clinical importance.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Determination of chitosan dose for administarion (Phase I: after 1 and 4 hours) and evaluation of symptoms and blood examination (Phase I: by 1 month). Correlation between blood concentration level of chitosan and disease activity of IBD (Phase II. at administration).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 chitosan
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients with Crohn's disease and ulcerative colitis
Key exclusion criteria Patients who physicians judge as inappropriate
Target sample size 132

Research contact person
Name of lead principal investigator
1st name Shunji
Middle name
Last name Ishihara
Organization Shimane University Faculty of Medicine
Division name Internal Medicine II
Zip code 693-8501
Address Enya-cho 89-1, Izumo, ShImane
TEL 0853-20-2190
Email si360405@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name Shunji
Middle name
Last name Ishihara
Organization Shimane University Faculty of Medicine
Division name Internal Medicine II
Zip code 693-8501
Address Enya-cho 89-1, Izumo, ShImane
TEL 0853-20-2190
Homepage URL
Email si360405@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Internal Medicine II
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Internal Medicine II
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 Medical Ethics Committee of Shimane University
Address Enya-cho 89-1, Izumo, ShImane
Tel 0853-20-2515
Email kenyu@med.shimane-u.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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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 Suspended
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 05 Month 25 Day
Anticipated trial start date
2018 Year 08 Month 05 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043830

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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