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

Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

This study is testing a new infant formula to see if it can help babies and young children with cow's milk allergy feel better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 61 (estimated)
• Ages: 3 Months to 12 Years
• Sex: All
• Sponsor: Abbott Nutrition (Industry-sponsored)
• Drugs / interventions: omalizumab
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT06456541 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include infants and children with confirmed IgE-mediated cow's milk allergy who have followed a strict cow's milk protein-free diet.

Not a fit: Patients who do not have a confirmed diagnosis of cow's milk allergy or those who are not willing to stop antihistamines or oral steroids prior to the study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a safe dietary option for infants and children suffering from cow's milk allergy.

How similar studies have performed: Previous studies have shown success with similar approaches in managing food allergies, indicating potential for this trial's success.

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:

  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 \>10mm;
  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.

Where this trial is running

Phoenix, Arizona and 8 other locations

• Phoenix Children's — Phoenix, Arizona, United States (Not_yet_recruiting)
• Children's Hospital Colorado — Aurora, Colorado, United States (Completed)
• 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)
• Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
• UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Kristen DeLuca

Conditions Cow's Milk Allergy