UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035741 |
|---|---|
| Receipt number | R000040582 |
| Scientific Title | A study on induction of oral immune tolerance in children with food allergy |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/01/22 21:35:46 |
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Basic information
Public title
A study on induction of oral immune tolerance in children with food allergy
Acronym
The effect of slow oral immunotherapy on food allergy
Scientific Title
A study on induction of oral immune tolerance in children with food allergy
Scientific Title:Acronym
The effect of slow oral immunotherapy on food allergy
Region
| Japan |
Condition
Condition
Food Allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to find trace amounts that can be ingested by children who present with food allergy symptoms in minimum dose and investigate whether food allergic children acquired immune tolerance by increasing to have food antigen slowly. Whether it can be increased without exhibiting severe allergic symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Children with food allergy can ingest a minimum dose of food antigen.
Key secondary outcomes
Children with food allergy do not develop severe allergic symptoms.
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children who has immediate allergic symptoms in oral food challenge due to minimum dose.
2. Childen diagnosed as having food allergy.
3. The children who gained written consent by free will from the patient himself or the substitute person after having sufficient explanation for participation in this research, with sufficient understanding.
Key exclusion criteria
1. With surgical history such as gastrointestinal resection surgery.
2. With immunodeficiency, bone strain disorder, malformation.
3. Children who judged that the research director is inappropriate as the research subject.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Baba |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
Address
Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL
055-948-3111
youbaba@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Baba |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Pediatrics
Zip code
Address
Nagaoka 1129, Izunokuni city, Shizuoka, Japan
TEL
055-948-3111
Homepage URL
youbaba@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine, Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
MEXT (Ministry of Education, Culture, Sports, Science and Technology) Supported Program for the Strategic Research Foundation at Private Universities Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
順天堂大学医学部附属静岡病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | 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
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective non-interventional observational study
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040582
