UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018372 |
|---|---|
| Receipt number | R000021272 |
| Scientific Title | A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy |
| Date of disclosure of the study information | 2015/07/24 |
| Last modified on | 2017/01/25 14:17:51 |
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Basic information
Public title
A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy
Acronym
A pilot study for the effect of jam oral immunotherapy with hypoallergenized cow's milk (JMIT study)
Scientific Title
A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy
Scientific Title:Acronym
A pilot study for the effect of jam oral immunotherapy with hypoallergenized cow's milk (JMIT study)
Region
| Japan |
Condition
Condition
food allergy (cow's milk)
Classification by specialty
| Clinical immunology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral imunotherapy with hypoallergenized cow's milk
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The threshold change of double blind placebo controlled oral food challenge test
Key secondary outcomes
1. Effectiveness
Change of specific IgE and IgG4 level for cow's milk, casein, B-lactoglobulin
2. Safety
a. The proportion of the patients who experienced allergic reactions within 2 hours after the ingestion of the hypoallergenized milk
b. The frequency of allergic reactions within 2 hours after the ingestion of the hypoallergenized milk
3. Edibility of jam containing hypoallergenized cow's milk
4. QOL assessment by the parents and of the parents
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
Slow oral immunotherapy with hypoallergenized cow's milk for 6 months
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
| 12 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with cow's milk allergy
2. Patients who failed to increase the threshold through conventional slow oral immunotherapy with cow's milk continued for more than six months
3. Patients whose cow's milk-specific IgE level was greater than 15 UA/ml within 8 weeks before registration
4. Patients diagnosed as cow's milk allergy by double blind placebo controlled food challenge test
5. Patients who can keep complete elimination of cow's milk from their diet
6. Patients whose family are cooperative enough to adhere to the protocol of this study
Key exclusion criteria
1. Patients with non-immediate reaction to cow's milk
2. Patients with uncontrolled asthma, atopic dermatitis or urticaria
3. Patients with pineapple or soy allergy
4. Patients who have treatment history or plan with omalizumab
5. Patients who were undergoing oral immunotherapy of build-up phase for other food antigen
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Ohya |
Organization
National Center for Child Health and Development
Division name
Division of Allergy
Zip code
Address
2-10-1 Okura Setagaya-ku Tokyo, 157-8535 Japan
TEL
03-3416-0181
ohya-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyuki Hashimoto |
Organization
National Center for Child Health and Development
Division name
Division of Allergy
Zip code
Address
2-10-1 Okura Setagaya-ku Tokyo, 157-8535 Japan
TEL
03-3416-0181
Homepage URL
hashimoto-my@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Grant from the National Center for Child Health and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sagami Women's Junior College Department of Food and Nutrition Science
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 24 | 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
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021272
