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

Cow's Milk Allergy Clinical Trial

Official title:

Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04910373
• Other study ID #: AL36
• Status: Terminated
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: February 18, 2022

Study information

• Verified date: June 2022
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Experimental Extensively Hydrolyzed Formula
experimental powder formula
• Placebo Extensively Hydrolyzed Formula
placebo powder formula

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	UNC-Chapel Hill	Chapel Hill	North Carolina
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Challenge Positive Reactions	Percent of positive food challenge reactions to the experimental formula	Food Challenge Day 1 to Food Challenge Day 2
Secondary	Experimental Formula Intake	Parent completed diaries of formula intake	Home Feeding Day 1 to Day 7
Secondary	Food Intake	Parent completed diaries	Home Feeding Day 1 to Day 7
Secondary	Gastrointestinal Symptoms	Parent completed diaries	Home Feeding Day 1 to Day 7
Secondary	Medication Use	Parent completed diaries	Home Feeding Day 1 to Day 7
Secondary	Food Challenge Positive Reactions	Percent of positive food challenge reactions to the experimental formula	Home Feeding Day 1 to Day 7