UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009373 |
|---|---|
| Receipt number | R000011019 |
| Scientific Title | Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. |
| Date of disclosure of the study information | 2012/12/01 |
| Last modified on | 2021/10/05 11:25:03 |
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Basic information
Public title
Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Acronym
Multicenter Outpatient Oral Immunotherapy
(MO-OIT)
Scientific Title
Multicenter Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.
Scientific Title:Acronym
Multicenter Outpatient Oral Immunotherapy
(MO-OIT)
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 target doses.
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 dose dependent outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient oral immunotherapy.
Patients are enrolled in two groups, which are divided by target amounts of OIT ingestion as 100% or 25% of maximum ingestion amount.
Key secondary outcomes
To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy.
To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children, performed by multicenter trial.
To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy.
Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent at each hospital with its will for participation in advance.
The outcome at 2 years' follow up is analyzed in addition to that at 1 year.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The target amount of ingestion, regarding tolerance acquisition, is defined one heated hen's egg, 100ml of cow's milk, and 100g of Japanese Udon noodles.
Interventions/Control_2
The maximum amount of ingestion at home is 100% amount of that in group A and 25% of that in group B, during one year oral immunotherapy.
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects, aged 3-15 years old, undergo oral food challenge within the 3 months before this trial.
They are confirmed mild or moderate positive objective symptoms caused by hen's egg, cow's milk, or wheat ingestion challenge.
The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a quarter of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 25ml, and that for wheat is more than 3g of Udon noodles and not greater than 25g of that.
Key exclusion criteria
The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg, 3ml of cow's milk, or 3g 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 | 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
foodallergy@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | Kiyotake |
| Middle name | |
| Last name | Ogura |
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
042-742-7311
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
Japanese Governmental office
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
National Hospital Organization Sagamihara National Hospital
Address
18-1, sakuradai, minamiku, sagamiharashi, 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 小児科（神奈川県）
昭和大学病院 小児科（東京都）
あいち小児保健医療総合センター アレルギー科（愛知県）
岐阜大学医学部附属病院 小児科（岐阜県）
藤田保健衛生大学 坂文種報徳會病院 小児科（愛知県）
国立病院機構 三重病院 アレルギー科（三重県）
国立病院機構 福岡病院 小児科（福岡県）
国立病院機構 横浜医療センター 小児科（神奈川県）
国立病院機構 福山医療センター 小児科（広島県）
東京慈恵会医科大学 分子疫学研究室（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.worldallergyorganizationjournal.org/article/S1939-4551(20)30366-5/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.worldallergyorganizationjournal.org/article/S1939-4551(20)30366-5/fulltext
Number of participants that the trial has enrolled
101
Results
The year 1 StU rates (%) for the 100%- and 25%-dose groups were 26.9 vs. 20.0 (HE), 7.7 vs. 15.4 (CM), and 50.0 vs. 16.7 (wheat), respectively. The year 2 StU rates were 30.8 vs. 36.0 (HE), 7.7 vs. 23.1 (CM), and 58.3 vs. 58.3 (wheat), respectively. There were no statistically significant differences in StU between years 1 and 2. The total allergic symptom rate in the 25%-dose group was lower than that in the 100%-dose group for egg, milk, and wheat.
Results date posted
| 2021 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 09 | Month | 29 | Day |
Baseline Characteristics
The age groups were from early childhood to middle school age, and their past history rates of anaphylaxis were approximately from 30-69%. The allergic symptom threshold at baseline OFC are expressed in Table 1.
Participant flow
Patients were assessed for eligibility based on their symptoms for HE, CM, or wheat allergies at the baseline oral food challenge (OFC) . The immediate type of FA was defined as having at least 1 or more objective allergic symptoms, or clinically significant subjective symptoms, confirmed by OFC within 3 months before the study.
Adverse events
The ratio of total adverse reactions per total ingestion times in the 25%-dose OIT group was significantly lower than that in the 100%-dose OIT group. Most of these allergic reactions during both OITs were mild. There were 5 cases of intramuscular adrenaline injections used during OIT. However, no cases of anaphylactic shock, respiratory failure or hypotension were observed.
Outcome measures
The primary endpoint was comparison of StU rates between the 100%- and 25%-dose groups in the first year. The secondary endpoints were: 1) StU rate at year 2 of follow-up; 2) immunological change and 3) rates of allergic symptoms and medication used during OIT ingestion for 2 years.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011019
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/06/19 | 99 moOIT_dataset (Anonymized).xlsx |
