UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033345 |
|---|---|
| Receipt number | R000038014 |
| Scientific Title | Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2020/07/10 13:28:15 |
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Basic information
Public title
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Acronym
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Scientific Title
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Scientific Title:Acronym
Randomized trial of ingestion method of oral immunotherapy for severe food allergic patients
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the appropriate method of OIT for patients with severe food allergy after achieving low-dose desensitization ("continuation of low-dose ingestion" vs "gradually increase up to middle-dose").
Low-dose was defined as "one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut".
Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained unresponsiveness to middle-dose after 12 months.
Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".
Key secondary outcomes
Changes of specific IgE, IgG, IgG4
Frequency of adverse reactions
The rate of sustained unresponsiveness to middle-dose after 5 years from start of OIT.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral immunotherapy with a target dose of middle-dose
Interventions/Control_2
Oral immunotherapy with ingestion of low-dose
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who performed low-dose oral immunotherapy (target dose of one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut) for 12 months or more.
Patients who achieved desensitization to low-dose and have been asymptomatic for 3 months or more.
Patients who failed middle-dose oral food challenge after 2 weeks of complete avoidance.
Key exclusion criteria
Decision of ineligibility by a physician
Target sample size
48
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, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
ssakura8010@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
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
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
AMED (Japan Agency for Medical Research and Development)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
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
国立病院機構相模原病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 10 | 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
| 2018 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2025 | 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
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038014
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/16 | 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/16 | Case Data Specifications.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/01/16 | Case data.xlsx |
