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Infant Formula for Cow's Milk Allergy

This study is looking at a new infant formula for babies and children with cow's milk allergy (CMA). Researchers want to see if an Experimental Extensively Hydrolyzed Formula is safe and effective compared to a Placebo Extensively Hydrolyzed Formula. To join, your child must be between 3 months and 12 years old and have a confirmed diagnosis of IgE-mediated CMA (a type of allergy where the body's immune system overreacts to cow's milk protein). The main goal is to see if children have allergic reactions during food challenges. The study is currently recruiting about 96 participants.

Study design
This is a multi-center study where participants are randomly assigned to receive either the experimental formula or a placebo. It is double-blinded, meaning neither you nor the study team will know which formula your child is receiving.
What's involved
Your child will participate in food challenges and then feed the experimental formula at home for 7 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for reactions during food challenges, with the second challenge occurring within 14 days of the first, followed by 7 days of home feeding.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06456541

Infant Formula in Infants and Children With Cow's Milk Allergy

Recruiting
NAAges 3–12Interventional
Abbott Nutrition
~96 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Experimental Extensively Hydrolyzed FormulaPlacebo Extensively Hydrolyzed Formula

At a glance

Recruiting sites
7 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Food Challenge Reactions
Measured over 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.)

Conditions

Cow's Milk Allergy

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Where it's being run

9 sites across 7 states
Ohio3
Arizona1
Colorado1
Illinois1
Michigan1
North Carolina1
Texas1

Who to contact

Kristen DeLuca
[email protected]
6145653522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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.

What this trial measures

  • Food Challenge ReactionsFood 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.