Recruiting NCT06456541
Infant Formula in Infants and Children With Cow's Milk Allergy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Extensively Hydrolyzed Formula, Placebo Extensively Hydrolyzed Formula.
- Who it may be relevant to
- Registry conditions: Cow's Milk Allergy. Basic parameters: 3 months — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Overview
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
- Other Experimental Extensively Hydrolyzed Formula
Experimental powder formula - Other Placebo Extensively Hydrolyzed Formula
Placebo powder formula
Primary outcome measures
- Food Challenge Reactions [Time frame: 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.)]
Secondary outcome measures (5)
- Volume of Experimental Formula Intake [Time frame: Home Feeding Day 1 to Day 7]
- Food Intake during Study [Time frame: Home Feeding Day 1 to Day 7]
- Gastrointestinal Symptoms [Time frame: Home Feeding Day 1 to Day 7]
- Medication Use [Time frame: Home Feeding Day 1 to Day 7]
- Food Challenge Positive Reactions [Time frame: Home Feeding Day 1 to Day 7]
Eligibility criteria
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:
- 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 ≥8mm;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
United States · 9 centers
- Phoenix Children's — Phoenix
- Children's Hospital Colorado — Aurora
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
- University of Michigan Food Allergy Clinic — Ann Arbor
- University of North Carolina at Chapel Hill — Chapel Hill
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Cleveland Clinic — Cleveland
- Nationwide Children's Hospital — Columbus
- … and 1 more center
Identifiers
NCT: NCT06456541 · AL60