Actively Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
Led by Abbott Nutrition · Updated on 2026-05-13
61
Participants Needed
9
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Infant Formula in Infants and Children With Cow's Milk Allergy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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: physician diagnosis of IgE-mediated CMA with clinical history and detectable serum milk-specific IgE >0.7 kU/L or positive skin prick test wheal ≥5 mm; documentation of milk-specific serum IgE >15 kU/L or >5 kU/L if younger than 1 year; documented cow's milk skin prick test wheal >10 mm; or physician-supervised oral food challenge with immediate 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 diagnosis confirmation 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 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 approved by an Ethics Committee/Institutional Review Board and provided applicable privacy authorization prior to participation.
You will not qualify if you...
- 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, FPIES, eosinophilic esophagitis, and severe uncontrolled eczema.
- Previous severe anaphylactic reaction to cow's milk within the last two years.
- Adverse medical history or current condition potentially affecting tolerance or hypoallergenicity testing.
- Participant has an allergy or intolerance to any ingredient in the study product.
- Participant is consuming baked milk products.
- Use of and/or changing dose of high potency steroids.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Phoenix Children's
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Completed
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
4
University of Michigan Food Allergy Clinic
Ann Arbor, Michigan, United States, 48106
Actively Recruiting
5
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
9
UT Southwestern Medical Center
Dallas, Texas, United States, 75207
Actively Recruiting
Research Team
K
Kristen DeLuca
CONTACT
J
Jane Schlezinger
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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