Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
Primary Purpose
Cow's Milk Allergy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental Extensively Hydrolyzed Formula
Placebo Extensively Hydrolyzed Formula
Sponsored by
About this trial
This is an interventional other trial for Cow's Milk Allergy
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:
- 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.
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.
Sites / Locations
- Children's Hospital Colorado
- Children's Healthcare of Atlanta
- UNC-Chapel Hill
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Extensively Hydrolyzed Formula
Placebo Extensively Hydrolyzed Formula
Arm Description
Administered during food challenge and at home feeding period
Administered during food challenge
Outcomes
Primary Outcome Measures
Food Challenge Positive Reactions
Percent of positive food challenge reactions to the experimental formula
Secondary Outcome Measures
Experimental Formula Intake
Parent completed diaries of formula intake
Food Intake
Parent completed diaries
Gastrointestinal Symptoms
Parent completed diaries
Medication Use
Parent completed diaries
Food Challenge Positive Reactions
Percent of positive food challenge reactions to the experimental formula
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04910373
Brief Title
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Product Availability Due to Recall
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
February 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Nutrition
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow's Milk Allergy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Extensively Hydrolyzed Formula
Arm Type
Experimental
Arm Description
Administered during food challenge and at home feeding period
Arm Title
Placebo Extensively Hydrolyzed Formula
Arm Type
Placebo Comparator
Arm Description
Administered during food challenge
Intervention Type
Other
Intervention Name(s)
Experimental Extensively Hydrolyzed Formula
Intervention Description
experimental powder formula
Intervention Type
Other
Intervention Name(s)
Placebo Extensively Hydrolyzed Formula
Intervention Description
placebo powder formula
Primary Outcome Measure Information:
Title
Food Challenge Positive Reactions
Description
Percent of positive food challenge reactions to the experimental formula
Time Frame
Food Challenge Day 1 to Food Challenge Day 2
Secondary Outcome Measure Information:
Title
Experimental Formula Intake
Description
Parent completed diaries of formula intake
Time Frame
Home Feeding Day 1 to Day 7
Title
Food Intake
Description
Parent completed diaries
Time Frame
Home Feeding Day 1 to Day 7
Title
Gastrointestinal Symptoms
Description
Parent completed diaries
Time Frame
Home Feeding Day 1 to Day 7
Title
Medication Use
Description
Parent completed diaries
Time Frame
Home Feeding Day 1 to Day 7
Title
Food Challenge Positive Reactions
Description
Percent of positive food challenge reactions to the experimental formula
Time Frame
Home Feeding Day 1 to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlett Ramirez
Organizational Affiliation
Abbott Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
UNC-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
We'll reach out to this number within 24 hrs