Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Abbott Nutrition
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.
Eligibility
- Age range
- 0–12 years
- Sex
- All
- 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 \>10…
Interventions
- OtherExperimental Extensively Hydrolyzed Formula
Experimental powder formula
- OtherPlacebo Extensively Hydrolyzed Formula
Placebo powder formula
Locations (8)
- Children's Hospital ColoradoAurora, Colorado
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, Illinois
- University of Michigan Food Allergy ClinicAnn Arbor, Michigan
- University of North Carolina at Chapel HillChapel Hill, North Carolina
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio
- Cleveland ClinicCleveland, Ohio