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

NCT ID: NCT04910373

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2022-02-18

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.

Conditions

Cow's Milk Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental Extensively Hydrolyzed Formula

Administered during food challenge and at home feeding period

Group Type: EXPERIMENTAL

Experimental Extensively Hydrolyzed Formula

Intervention Type: OTHER

experimental powder formula

Placebo Extensively Hydrolyzed Formula

Administered during food challenge

Group Type: PLACEBO_COMPARATOR

Placebo Extensively Hydrolyzed Formula

Intervention Type: OTHER

placebo powder formula

Interventions

Experimental Extensively Hydrolyzed Formula

experimental powder formula

Intervention Type: OTHER

Placebo Extensively Hydrolyzed Formula

placebo powder formula

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlett Ramirez

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

UNC-Chapel Hill

Chapel Hill, North Carolina, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

AL36

Identifier Type: -

Identifier Source: org_study_id