UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034085 |
|---|---|
| Receipt number | R000038858 |
| Scientific Title | Oral food challenge test for food-allergic children at outpatient clinic |
| Date of disclosure of the study information | 2018/10/02 |
| Last modified on | 2019/03/28 18:42:50 |
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Basic information
Public title
Oral food challenge test for food-allergic children at outpatient clinic
Acronym
Oral food challenge test for food-allergic children at outpatient clinic
Scientific Title
Oral food challenge test for food-allergic children at outpatient clinic
Scientific Title:Acronym
Oral food challenge test for food-allergic children at outpatient clinic
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To provide precise nutritional guidance of each allergens.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To provide remission of allergens
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
To eat allergens
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
| 6 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Food allergy patient who is not likely to have symptoms by eating allergens.
Key exclusion criteria
Food allergy patient who is likely to have symptoms by eating allergens.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Tokuyama |
Organization
Saitama medical university hospital
Division name
Pediatrics
Zip code
Address
morohongo38, moroyama-cho, iruma-gun, Saitama-prf
TEL
049-276-1218
y_ueda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ueda Yutaka |
Organization
Saitama Medical University Hospital
Division name
Pediatrics
Zip code
Address
morohongo38, moroyama-cho, iruma-gun, Saitama-prf
TEL
049-276-1218
Homepage URL
y_ueda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital,
department of pediatrics
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University Hospital,
department of pediatrics
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
Address
Tel
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
| 2018 | Year | 10 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038858
