UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011684 |
|---|---|
| Receipt number | R000013665 |
| Scientific Title | Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2021/01/26 13:08:47 |
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Basic information
Public title
Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Acronym
Outpatient Oral Immunotherapy
Scientific Title
Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Scientific Title:Acronym
Outpatient Oral Immunotherapy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of outpatient oral immunotherapy for food allergy focusing on mild and moderate food allergic children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The purpose of this study is to clarify outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient slow oral immunotherapy.
Key secondary outcomes
To investigate the efficacy of oral immunotherapy, compared to natural course without this therapy.
To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children.
To analyze the incidence rate of symptoms with or without using antihistamine drug during build-up phase.
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
The target amount of ingestion, regarding tolerance acquisition, is defined one heated hen's egg, 200ml of cow's milk, and 100g of Japanese Udon noodles.
The subjects are asked to take a small amount of their causative food at home, and it is built up to target amount gradually depending on their symptoms.
Interventions/Control_2
The subjects are divided into the two groups at random. The one group is "with antihistamine group" which use it during the build up phase. The other group is "without antihistamine group" which do not use It.
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 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects are confirmed mild or moderate positive objective symptoms caused by hen's egg, cow's milk, or wheat ingestion challenge just before this trial.
Key exclusion criteria
The threshold for eliciting positive symptoms is less than one fourth hen's egg, 12ml of cow's milk, or 7g of Udon noodles by oral food challenge test.
The subject who is treated by adrenaline injection at oral food challenge test just before this study.
The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease.
The subject who is not appropriate for oral immunotherapy, judged by medical doctor.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Ebisawa |
Organization
National Hospital Organization
Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
foodallergy@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Imai Takanori |
Organization
National Hospital Organization
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
Homepage URL
foodallergy@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Research grant by the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Network research of National Hospital Organization
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
国立病院機構 相模原病院 小児科（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2009 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2021 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013665
