Clinical trial NCT04910373: Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Official title: Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cow's Milk Allergy
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Food Challenge Positive Reactions
timeFrame: Food Challenge Day 1 to Food Challenge Day 2
Secondary outcomes:
measure: Experimental Formula Intake
timeFrame: Home Feeding Day 1 to Day 7
measure: Food Intake
timeFrame: Home Feeding Day 1 to Day 7
measure: Gastrointestinal Symptoms
timeFrame: Home Feeding Day 1 to Day 7
measure: Medication Use
timeFrame: Home Feeding Day 1 to Day 7
measure: Food Challenge Positive Reactions
timeFrame: Home Feeding Day 1 to Day 7
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Abbott Nutrition
name: Carlett Ramirez
role: STUDY_CHAIR
References: