UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042863 |
|---|---|
| Receipt number | R000048926 |
| Scientific Title | Investigating intestinal immune disorders in psoriasis |
| Date of disclosure of the study information | 2020/12/28 |
| Last modified on | 2022/12/31 16:56:10 |
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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
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
yosuke.shimodaira@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048926
