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

Abbott

Status: Enrolling

Conditions: Cow's Milk Allergy

Treatments: Other: Experimental Extensively Hydrolyzed Formula; Other: Placebo Extensively Hydrolyzed Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT06456541

AL60

Details and patient eligibility

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.

Enrollment: 61 estimated patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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 of 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Experimental Extensively Hydrolyzed Formula

Experimental group

Description:

Administered during food challenge and at home feeding period of 7 days

Treatment:

Other: Experimental Extensively Hydrolyzed Formula

Placebo Extensively Hydrolyzed Formula

Placebo Comparator group

Description:

Administered during food challenge

Treatment:

Other: Placebo Extensively Hydrolyzed Formula