UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011202 |
|---|---|
| Receipt number | R000013127 |
| Scientific Title | Small amount induction oral Immunotherapy for Hen's Egg, Cow's Milk, Wheat, and Peanut allergic children. |
| Date of disclosure of the study information | 2013/07/19 |
| Last modified on | 2023/06/23 21:25:04 |
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Basic information
Public title
Small amount induction oral Immunotherapy for Hen's Egg, Cow's Milk, Wheat, and Peanut allergic children.
Acronym
Small amount induction Oral Immunotherapy
Scientific Title
Small amount induction oral Immunotherapy for Hen's Egg, Cow's Milk, Wheat, and Peanut allergic children.
Scientific Title:Acronym
Small amount induction 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 small amount induction oral immunotherapy for food allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Because description of primary outcome was insufficient, we have revised it as follows.
The rate of sustained unresponsiveness* to middle-dose** after 1 year
*Sustained unresponsiveness is defined as "when patients passed the OFC of middle-dose after the complete avoidance for 2 weeks".
**Middle-dose is defined as "half of a whole egg, 25 ml of cow's milk, 15g of Udon, 3g of peanut".
Key secondary outcomes
Because description of key secondary outcomes was insufficient, we have revised it as follows.
1. Frequency of adverse reactions
2. The rate of sustained unresponsiveness* to middle-dose** or full-dose*** after 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, and 10 years from start of OIT.
3. Changes of specific IgE, IgG and IgG4
4. Comparison with rush oral immunotherapy (adverse reactions, the rate of sustained unresponsiveness to middle-dose and full-dose, and changes of specific IgE) after 1 year, 2 years, 3 years, 4 years 5 years, 6 years, 7 years, 8 years, 9 years, and 10 years from start of OIT.
*Sustained unresponsiveness is defined as "when patients passed the OFC of middle-dose or full-dose after the complete avoidance for 2 weeks".
**Middle dose is defined as "half of a whole egg, 25 ml of cow's milk, 15g of Udon, 3g of peanut".
***Full dose is defined as "whole egg, 50-200 ml of cow's milk, 50-200g of Udon and 5-10g of peanuts".
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The target amount of ingestion, regarding tolerance acquisition, is defined one thirty-seconds hen's egg, 3ml of cow's milk, 2g of Japanese Udon noodles, and 0.5g of peanut.
The subjects are asked to take a small amount of their causative food at inpatient department, and it is built up to target amount gradually depending on their symptoms.
The subjects continue their causative foods ingestion after discharge from the hospital during one year.
If the patient has consumed a small dose of the causative food at home for more than 1 year, the consumption of the causative food should be discontinued for 2 weeks and an OFC will be performed.
If the OFC is negative, the patient should continue to consume middle or high doses of the causative food, and the next OFC will be performed.
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Because description of key inclusion criteria was insufficient, we have revised it as follows.
The patients who visit to our hospital and exert objective symptoms based on the oral food challenge with one of the following food products are included to this study; 1/32 of a heated whole egg (194mg of egg protein), 3ml of cow's milk (102mg of milk protein), 2g of Udon (53mg of wheat protein) or 0.5g of whole peanut (133mg of peanut protein).
Objective symptoms is based as on the anaphylaxis guideline by Japanese Society of Allergology (Yanagida N. et al Allergol Int 2016, Ebisawa M. et al Allergol Int 2017.)
Key exclusion criteria
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
100
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Yanagida |
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
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)
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 | 07 | Month | 19 | 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
| 2013 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 16 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013127
