food allergy (cow'
Conditions
Interventions
Slow oral immunotherapy with hypoallergenized cow'
s milk for 6 months
Sponsors
National Center for Child Health and Development
Sagami Women'
s Junior College Department of Food and Nutrition Science
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The threshold change of double blind placebo controlled oral food challenge test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMiyuki Hashimoto
National Center for Child Health and Development Division of Allergy
Outcome results
None listed