Cow's Milk Allergy
Conditions
Brief summary
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and 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's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment: 1. Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \>0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm; 2. Documentation of milk-specific serum IgE ≥15 kUᴀ/L or ≥ 5 kUᴀ/L if younger than 1 year; 3. Documented cow's milk skin prick test wheal ≥8mm; 4. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms. * Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges. * Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment. * Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study. * Participant is between 3 months and 12 years of age at enrollment. * 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 partially or 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, eczema and/or food allergies 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 consuming baked milk products. * Use of and/or changing dose of high potency steroids. * Participant is treated with any oral immunotherapy (sublingual, subcutaneous, and epicutaneous) for any food allergy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food Challenge Reactions | Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.) | Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Experimental Formula Intake | Home Feeding Day 1 to Day 7 | Parent completed diaries of Intake |
| Food Intake during Study | Home Feeding Day 1 to Day 7 | Parent completed daily food 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
Contacts
CONTACTKristen DeLuca
CONTACTJane Schlezinger
Outcome results
None listed