Cow's Milk Allergy
Conditions
Brief summary
This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.
Interventions
experimental powder formula
placebo powder formula
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation * Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment: 1. Documentation of milk-specific serum IgE \>15 kIUA/L or \> 5 kIUA/L if younger than 1 year. 2. Documented cow's milk skin prick test mean wheal \>10mm 3. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms. * Participant agrees to stop oral steroid use within 14 days and antihistamine use within 7 days of confirmation of diagnosis and food challenges. * Participant had followed a strict cow's milk protein-free diet prior to enrollment. * Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study. * Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Exclusion criteria
* Participant is exclusively breastfed at the time of enrollment. * Participant is consuming an amino acid-based formula due to failure on an extensively hydrolyzed formula. * Significant chronic medical diseases including major chromosomal or congenital anomalies, gastrointestinal diseases or abnormalities other than CMA, immunodeficiencies, unstable asthma, asthma treated with biologics (omalizumab or other monoclonal antibody), FPIES, eosinophilic esophagitis, and severe uncontrolled eczema. * Previous severe anaphylactic reaction to cow's milk within the last two years. * An adverse medical history or current condition that is thought by the investigator to have potential for effects on tolerance or the hypoallergenicity test. * Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent. * Participant is routinely consuming baked milk products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Challenge Positive Reactions | Food Challenge Day 1 to Food Challenge Day 2 | Percent of positive food challenge reactions to the experimental formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experimental Formula Intake | Home Feeding Day 1 to Day 7 | Parent completed diaries of formula intake |
| Food Intake | Home Feeding Day 1 to Day 7 | Parent completed diaries |
| Gastrointestinal Symptoms | Home Feeding Day 1 to Day 7 | Parent completed diaries |
| Medication Use | Home Feeding Day 1 to Day 7 | Parent completed diaries |
| Food Challenge Positive Reactions | Home Feeding Day 1 to Day 7 | Percent of positive food challenge reactions to the experimental formula |
Countries
United States
Outcome results
None listed