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

NCT04910373 | Terminated

• 1 other identifier: AL36
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Food Challenge Positive Reactions

  Percent of positive food challenge reactions to the experimental formula

  Food Challenge Day 1 to Food Challenge Day 2

Secondary Outcomes (5)

• Experimental Formula Intake

  Home Feeding Day 1 to Day 7

• Food Intake

  Home Feeding Day 1 to Day 7

• Gastrointestinal Symptoms

  Home Feeding Day 1 to Day 7

• Medication Use

  Home Feeding Day 1 to Day 7

• Food Challenge Positive Reactions

  Home Feeding Day 1 to Day 7

Study Arms (2)

Experimental Extensively Hydrolyzed Formula

EXPERIMENTAL

Administered during food challenge and at home feeding period

Other: Experimental Extensively Hydrolyzed Formula

Placebo Extensively Hydrolyzed Formula

PLACEBO COMPARATOR

Administered during food challenge

Other: Placebo Extensively Hydrolyzed Formula

Interventions

Experimental Extensively Hydrolyzed Formula OTHER

experimental powder formula

Experimental Extensively Hydrolyzed Formula

Placebo Extensively Hydrolyzed Formula OTHER

placebo powder formula

Placebo Extensively Hydrolyzed Formula

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Documentation of milk-specific serum IgE \>15 kIUA/L or \> 5 kIUA/L if younger than 1 year.
• Documented cow's milk skin prick test mean wheal \>10mm
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (4)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Carlett Ramirez

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 2, 2021
• Study Start: January 25, 2022
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)