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

NCT06456541 | Recruiting

• 1 other identifier: AL60
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and 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 Reactions

  Percent of positive food challenge reactions to the experimental formula administered to cow's milk allergic infants and children.

  Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1) (followed by 7 days of feeding the experimental formula at home.)

Secondary Outcomes (5)

• Volume of Experimental Formula Intake

  Home Feeding Day 1 to Day 7

• Food Intake during Study

  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 of 7 days

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's parent(s) is/are willing for their child to undergo confirmatory testing or must have had at least one of the following within 6 months of enrollment:
• Physician diagnosis of IgE-mediated CMA, according to the participant's clinical history (e.g. gastrointestinal symptoms, hives, respiratory symptoms or angioedema) AND, detectable serum milk-specific IgE \>0.7 kUᴀ/L or positive skin prick test wheal ≥5 mm;
• Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/L if younger than 1 year;
• Documented cow's milk skin prick test wheal \>10mm;
• Physician-supervised oral food challenge that elicited immediate, objective, allergic symptoms.
• Participant's parent(s) agree for their child to stop oral steroid use within 14 days and antihistamine use within 7 days prior to confirmation of diagnosis and food challenges.
• Participant had followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment.
• Parent(s) confirm their intention not to administer any products containing cow's milk protein during the study.
• Participant is between 3 months and 12 years of age at enrollment.
• 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 partially or 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, eczema and/or food allergies 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 consuming baked milk products.
• Use of and/or changing dose of high potency steroids.

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (8)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

University of Michigan Food Allergy Clinic

Ann Arbor, Michigan, 48106, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75207, United States

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kristen DeLuca

CONTACT

6145653522; kristen.deluca@abbott.com

Jane Schlezinger

CONTACT

+44 (0) 1628 77355; jane.schlezinger@abbott.com

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: June 4, 2024
• First Posted: June 13, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)