UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041637 |
|---|---|
| Receipt number | R000047483 |
| Scientific Title | A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy |
| Date of disclosure of the study information | 2020/09/02 |
| Last modified on | 2020/11/06 19:29:20 |
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Basic information
Public title
A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Acronym
Low-dose oral immunotherapy for preschool-aged children
Scientific Title
A randomized controlled trial of low-dose oral immunotherapy for preschool-aged children with food allergy
Scientific Title:Acronym
Low-dose oral immunotherapy for preschool-aged children
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of low-dose oral immunotherapy for preschool-aged children with food allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of negative oral food challenge to the low-dose* after 1 year
*The low-dose is defined as"1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut".
Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Food |
Interventions/Control_1
The target amount of ingestion is defined as 1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of cow's milk, 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut.
The subjects are asked to take a small amount of their causative food at the inpatient department. The amount is gradually built up to their target amount depending on their symptoms.
The subjects continue to ingest their causative foods for a year after discharge from the hospital.
*Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.
Interventions/Control_2
The subjects continue to eliminate their causative foods for a year.
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
| 3 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 1/25 of a heated whole hen's egg (250mg of hen's egg protein), 3ml of milk, and 2g of udon, 0.5g of peanut, walnut, cashew, hazelnut, almond, and macadamia nut.
Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.).
*Walnut, cashew, hazelnut, almond, and macadamia nut were added on November 6, 2020, before enrollment of first patient.
Key exclusion criteria
The subject who has poorly treated atopic dermatitis and bronchial asthma.
The subject suspected with Food-protein induced enterocolitis syndrome.
The subject whose body weight is less than 10 kg.
The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Ebisawa |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
mebisawa@foodallergy.jp
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nagakura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan
TEL
042-742-8311
Homepage URL
k.nagakura@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
Tel
042-742-8311
222-rinri@mail.hosp.go.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
| 2020 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 01 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047483
