UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yukihiro Ohya
Organization	National Center for Child Health and Development
Division name	Division of Allergy
Address	2-10-1 Okura Setagaya-ku Tokyo, 157-8535 Japan
TEL	03-3416-0181
Email	ohya-y@ncchd.go.jp

Public contact
Name of contact person	Miyuki Hashimoto
Organization	National Center for Child Health and Development
Division name	Division of Allergy
Address	2-10-1 Okura Setagaya-ku Tokyo, 157-8535 Japan
TEL	03-3416-0181
Homepage URL
Email	hashimoto-my@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021272