Testing an infant formula for children with cow's milk allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial involves a multi-center, randomized, double-blinded, placebo-controlled food challenge aimed at infants and children diagnosed with IgE-mediated cow's milk allergy. Participants will undergo confirmatory testing and then be given either an experimental extensively hydrolyzed formula or a placebo for a 7-day open feeding period. The study seeks to evaluate the safety and efficacy of the new formula in managing cow's milk allergy symptoms.

Why it matters

Who can join: the full rules

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 ≥8mm;
  4. 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.

Where it's running

• Phoenix Children's
  Phoenix, Arizona, United States Recruiting
• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• University of Michigan Food Allergy Clinic
  Ann Arbor, Michigan, United States Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Kristen DeLuca
• Email: kristen.deluca@abbott.com
• Phone: 6145653522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.