Infant Formula in Infants and Children With Cow's Milk Allergy
ConditionCow's Milk Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorAbbott Nutrition
About this trial
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 criteria
Qualifiers
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;
Documentation of milk-specific serum IgE >15 kUᴀ/L or > 5 kUᴀ/L if younger than 1 year;
Documented cow's milk skin prick test wheal >10mm;
Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
Disqualifiers
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.,
Trial design
Treatments tested in this trial
- Experimental Extensively Hydrolyzed Formula
- Placebo Extensively Hydrolyzed Formula
Treatment groups
61 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov