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

Not Applicable

Terminated

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

• Registration Number: NCT04910373
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-27
• Study First Posted: 2021-06-02
• Study Start: 2022-01-25
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & 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 Positive Reactions	Food Challenge Day 1 to Food Challenge Day 2	Percent of positive food challenge reactions to the experimental formula

Secondary Outcome Measures

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

Trial Locations

Locations (4)

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

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States