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

Not Applicable

Recruiting

• Conditions: Cow's Milk Allergy
• Interventions: Other: Placebo Extensively Hydrolyzed Formula; Other: Experimental Extensively Hydrolyzed Formula

• Registration Number: NCT06456541
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-07
• Study First Posted: 2024-06-13
• Study Start: 2024-10-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-04
• Primary Completion: 2028-07
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Extensively Hydrolyzed Formula	Placebo Extensively Hydrolyzed Formula	Administered during food challenge
Experimental Extensively Hydrolyzed Formula	Experimental Extensively Hydrolyzed Formula	Administered during food challenge and at home feeding period

Primary Outcome Measures

Name	Time	Method
Food Challenge Reactions	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.)	Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.

Secondary Outcome Measures

Name	Time	Method
Food Intake during Study	Home Feeding Day 1 to Day 7	Parent completed daily food diaries
Gastrointestinal Symptoms	Home Feeding Day 1 to Day 7	Parent completed diaries
Medication Use	Home Feeding Day 1 to Day 7	Parent completed diaries
Volume of Experimental Formula Intake	Home Feeding Day 1 to Day 7	Parent completed diaries of Intake
Food Challenge Positive Reactions	Home Feeding Day 1 to Day 7	Percent of positive food challenge reactions to the experimental formula

Trial Locations

Locations (8)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

University of Michigan Food Allergy Clinic; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States