Extensively Hydrolyzed 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-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental formula.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC-Chapel Hill
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participant has a physician diagnosis of IgE-mediated Cow's Milk Allergy (CMA) based on a clinical history of a reaction resulting in characteristic immediate hypersensitivity symptoms within 2 hours of oral exposure or immediate hypersensitivity symptoms according to physician's observation

• Participant is willing to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:

  1. Documentation of milk-specific serum IgE >15 kIUA/L or > 5 kIUA/L if younger than 1 year.
  2. Documented cow's milk skin prick test mean wheal >10mm
  3. Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
• Participant agrees 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 prior to enrollment.
• Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
• 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 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, asthma 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 routinely consuming baked milk products.

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
Experimental: Experimental Extensively Hydrolyzed Formula; Administered during food challenge and at home feeding period	Other: Experimental Extensively Hydrolyzed Formula; experimental powder formula
Placebo Comparator: Placebo Extensively Hydrolyzed Formula; Administered during food challenge	Other: Placebo Extensively Hydrolyzed Formula; placebo powder formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Challenge Positive Reactions	Percent of positive food challenge reactions to the experimental formula	Food Challenge Day 1 to Food Challenge Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experimental Formula Intake	Parent completed diaries of formula intake	Home Feeding Day 1 to Day 7
Food Intake	Parent completed diaries	Home Feeding Day 1 to Day 7
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

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: AL36

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