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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042863
Receipt No. R000048926
Scientific Title Investigating intestinal immune disorders in psoriasis
Date of disclosure of the study information 2020/12/28
Last modified on 2020/12/27

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Basic information
Public title Investigating intestinal immune disorders in psoriasis
Acronym Intestinal immune disorders in psoriasis
Scientific Title Investigating intestinal immune disorders in psoriasis
Scientific Title:Acronym Intestinal immune disorders in psoriasis
Region
Japan

Condition
Condition Inflammatory bowel disease, psoriasis
Classification by specialty
Gastroenterology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the intestinal immune disorders in psoriasis patients
Basic objectives2 Others
Basic objectives -Others Investigate the effect of IL17 blocking in intestinal homeostasis
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes intestinal microbiota, RNA expression in intestinal mucosa, inflammatory marker in feces
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Psoriasis patients being treated in Akita University Hospital
Performance Status 0
Persons who agreed to attend the study and filled the consent form
Key exclusion criteria Persons with severe comobidities or uncontrolled mental disorders
Persons who did not agree to attend the study
Persons who are not suitable for this study.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yosuke
Middle name
Last name Shimodaira
Organization Akita University Graduate School of Medicine
Division name Gastroenterology and Neurology
Zip code 0108543
Address 1-1-1 Hondo, Akia city, Japan
TEL 018-884-6104
Email yosuke.shimodaira@med.akita-u.ac.jp

Public contact
Name of contact person
1st name Yosuke
Middle name
Last name Shimodaira
Organization Akita University Graduate School of Medicine
Division name Gastroenterology and Neurology
Zip code 0108543
Address 1-1-1 Hondo, Akia city, Japan
TEL 018-884-6104
Homepage URL
Email yosuke.shimodaira@med.akita-u.ac.jp

Sponsor
Institute Akita University
Institute
Department

Funding Source
Organization N/A
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 Akita University
Address 1-1-1 Hondo, Akita city, Japan
Tel 018-833-1166
Email soken@hos.akita-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
2020 Year 12 Month 28 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
2020 Year 06 Month 24 Day
Date of IRB
2020 Year 06 Month 24 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relation between skin immune disorders psoriasis and intestinal mucosal immune disorders inflammatory bowel disease was not fully investigated. In this study, intestinal immune homeostasis is being investigated in psoriasis patients.

Management information
Registered date
2020 Year 12 Month 27 Day
Last modified on
2020 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048926

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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