UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037182 |
|---|---|
| Receipt number | R000042369 |
| Scientific Title | Analysis of histone deacetylase inhibitory ability of food allergic children |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2023/06/29 18:32:50 |
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Basic information
Public title
Analysis of histone deacetylase inhibitory ability of food allergic children
Acronym
Analysis of epigenetics in food allergic children
Scientific Title
Analysis of histone deacetylase inhibitory ability of food allergic children
Scientific Title:Acronym
Analysis of epigenetics in food allergic children
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that HDAC inhibitory ability is useful as a prognostic marker for food allergy.
Basic objectives2
Others
Basic objectives -Others
Search for new biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
remission rate
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
| 1 | months-old | <= |
Age-upper limit
| 180 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Children diagnosed with food allergy
Key exclusion criteria
Cases in which the doctor in charge judged that it was better to stop the examination.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Yamazaki |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
0338133111
susumu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Yamazaki |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Pediatrics and Adolescent Medicine
Zip code
113-8431
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
0338133111
Homepage URL
susumu@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jaoan society for the promotion of the sience
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
Tel
0338133111
susumu@juntendo.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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
6
Results
We investigated in food-allergic children, but there were many error values in each analysis value, and there was a wide range of control (adult cases), and no significant results were obtained.
Results date posted
| 2023 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
food allergy child
Participant flow
Children who have given consent at an allergy outpatient clinic
Adverse events
None
Outcome measures
Blood butyric acid levels and histone deacetylase inhibitory activity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 07 | 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
nothing
Management information
Registered date
| 2019 | Year | 06 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042369
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
