Infant Formula in Infants and 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 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.

Study Overview

• Status: Recruiting
• Conditions: Cow's Milk Allergy
• Intervention / Treatment: Other: Experimental Extensively Hydrolyzed Formula; Other: Placebo Extensively Hydrolyzed Formula

• Study Type: Interventional
• Enrollment (Estimated): 61
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen DeLuca; Phone Number: 6145653522; Email: kristen.deluca@abbott.com
• Study Contact Backup: Name: Jane Schlezinger; Phone Number: +44 (0) 1628 77355; Email: jane.schlezinger@abbott.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Not yet recruiting
      • Phoenix Children's
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Completed
      • Children's Hospital Colorado
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Recruiting
      • University of Michigan Food Allergy Clinic
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75207
      • Recruiting
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Extensively Hydrolyzed Formula; Administered during food challenge	Other: Placebo Extensively Hydrolyzed Formula; Placebo powder formula
Experimental: Experimental Extensively Hydrolyzed Formula; Administered during food challenge and at home feeding period of 7 days	Other: Experimental Extensively Hydrolyzed Formula; Experimental powder formula

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: AL60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No