UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056182 |
|---|---|
| Receipt number | R000064199 |
| Scientific Title | The Gut microbiome analysis of skin diseases and health. |
| Date of disclosure of the study information | 2024/11/25 |
| Last modified on | 2024/11/18 15:06:04 |
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Basic information
Public title
The Gut microbiome analysis of skin diseases and health.
Acronym
The Gut microbiome analysis of skin diseases and health.
Scientific Title
The Gut microbiome analysis of skin diseases and health.
Scientific Title:Acronym
The Gut microbiome analysis of skin diseases and health.
Region
| Japan |
Condition
Condition
Atopic dermatitis, Psoriasis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Many reports suggest the interaction between gut microbiome and skin diseases such as atopic dermatitis and psoriasis.
In this study, we analyze gut microbiome from atopic dermatitis and psoriasis patients and healthy volunteers.
We will also reveal the underlying mechanisms of skin and gut interaction.
Basic objectives2
Others
Basic objectives -Others
Hyaluronic acid and Reg3A concentration in the serum.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Alpha and Beta diversity of gut microbiome in each condition
Specific gut microbes or genes from bacteria in each condition.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with Atopic dermatitis or Psoriasis by specialists.
People who don't have skin diseases and GI diseases.
Key exclusion criteria
Patients who have heart, neuron, kidney, and liver diseases.
Patients who used antibiotics within 1 month.
Younger than 15 years old and older than 65 years old.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | mikihiro |
| Middle name | |
| Last name | fujiya |
Organization
Asahikawa Medical University
Division name
Division of Gastroenterology, Department of Internal Medicine,
Zip code
0788510
Address
2-1-1-1 midorigaoka higashi, asahikawa city, Hokkaido
TEL
0166682462
fjym@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | tatsuya |
| Middle name | |
| Last name | dokoshi |
Organization
asahikawa medical university
Division name
Division of Gastroenterology, Department of Internal Medicine,
Zip code
0788510
Address
2-1-1-1 midorigaoka higashi, asahikawa city, Hokkaido
TEL
0166682462
Homepage URL
ta1983@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa medical university
Institute
Department
Personal name
Funding Source
Organization
Asahikawa medical university
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
Ethics Committee, Asahikawa Medical University
Address
2-1-1-1 midorigaoka higashi, asahikawa city, Hokkaido
Tel
0166-68-2297
rs-kp.g@asahikawa-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064199
