UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056270 |
|---|---|
| Receipt number | R000064131 |
| Scientific Title | Analysis of Intestinal/Skin Microbiota and Blood Markers during the Transition from Infantile Eczema to Atopic Dermatitis: An Infant Cohort Study |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/11/13 10:49:17 |
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Basic information
Public title
Analysis of Intestinal/Skin Microbiota and Blood Markers during the Transition from Infantile Eczema to Atopic Dermatitis
Acronym
Analysis of Intestinal/Skin Microbiota and Blood Markers during the Transition from Infantile Eczema to Atopic Dermatitis
Scientific Title
Analysis of Intestinal/Skin Microbiota and Blood Markers during the Transition from Infantile Eczema to Atopic Dermatitis: An Infant Cohort Study
Scientific Title:Acronym
Analysis of Intestinal/Skin Microbiota and Blood Markers during the Transition from Infantile Eczema to Atopic Dermatitis
Region
| Japan |
Condition
Condition
Atopic Dermatitis/Eczema
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigating the intestinal/skin environment and blood markers of infants associated with the development of atopic dermatitis in infants with eczema.
Basic objectives2
Others
Basic objectives -Others
Investigating the intestinal/skin environment and blood markers of infants associated with the development of atopic dermatitis in infants with eczema.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
No medical efficacy or safety evaluations will be conducted in this study.
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
| 2 | weeks-old | <= |
Age-upper limit
| 14 | months-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Male and female infants aged 0-1 month who have skin problems such as infantile eczema upon visiting the clinic.
(2) Those whose guardians have received an explanation of the study, are able to understand its contents, and can provide written consent.
Key exclusion criteria
(1) Those with a history of serious illness.
(2) Those who have taken or applied antibiotics within one month prior to obtaining consent.
(3) Those who have treated eczema with medications other than moisturizers, such as steroids, before participating in the study.
(4) Those who are deemed ineligible by the study representative or principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University
Division name
Institute of Advanced Bioscience
Zip code
9970052
Address
246-2, Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
0235-29-0528
sfukuda@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Keio University
Division name
Institute of Advanced Bioscience
Zip code
9970052
Address
246-2, Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
0235-29-0528
Homepage URL
sfukuda@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Yamagata Prefectural Government and the City of Tsuruoka
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
内野産婦人科外科小児科（東京都）
産婦人科小児科三井病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research design: Cohort Study (Exploratory)
Recruitment method: The physician in charge at the cooperating institutions will explain the study to the guardians of patients who have been diagnosed with skin problems and obtain their consent. Those who have agreed to participate in the study of their guardians' free will, meet the selection criteria, and do not violate the exclusion criteria will be included in the study.
Recruitment period (expected): A year from December 2024
Management information
Registered date
| 2024 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064131
