RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Determination of Hypoallergenicity of an Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy

Quick Facts

Study Start:2024-10-01

Study Completion:2029-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06456541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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 kUᴀ/L or positive skin prick test wheal ≥5 mm; 2. Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/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.	* 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.

Inclusion Criteria

Exclusion 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 kUᴀ/L or positive skin prick test wheal ≥5 mm;
2. Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/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.

* 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.

Contacts and Locations

Study Contact

Kristen DeLuca

CONTACT

6145653522

kristen.deluca@abbott.com

Study Locations (Sites)

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

UT Southwestern Medical Center

Dallas, Texas, 75207

United States

Collaborators and Investigators

Sponsor: Abbott Nutrition

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2029-01

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

Cow's Milk Allergy