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: Not yet recruiting

Administrative data

• NCT number: NCT06456541
• Other study ID #: AL60
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 2029

Study information

• Verified date: June 2024
• Source: Abbott Nutrition
• Contact: Kristen DeLuca
• Phone: 6145653522
• Email: kristen.deluca[@]abbott.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 61
• Est. completion date: January 2029
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

Inclusion Criteria:

• 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:

1. 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 kUA/L or positive skin prick test wheal =5 mm;

2. Documentation of milk-specific serum IgE >15 kUA/L or > 5 kUA/L if younger than 1 year;

3. Documented cow's milk skin prick test wheal >10mm;

4. 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 of 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.

Exclusion Criteria:

• 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, 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 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
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Challenge Reactions	Percent of positive food challenge reactions to the experimental formula	Food Challenge 1 to Food Challenge 2 (within 14 days of the Food Challenge 1)
Secondary	Volume of Experimental Formula Intake	Parent completed diaries of Intake	Home Feeding Day 1 to Day 7
Secondary	Food Intake during Study	Parent completed daily food 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