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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 3 Months - 12 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04910373
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Abbott Nutrition
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Carlett Ramirez
Principal Investigator Affiliation Abbott Nutrition
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cow's Milk Allergy
Arms & Interventions

Arms

Experimental: Experimental Extensively Hydrolyzed Formula

Administered during food challenge and at home feeding period

Placebo Comparator: Placebo Extensively Hydrolyzed Formula

Administered during food challenge

Interventions

Other: - Experimental Extensively Hydrolyzed Formula

experimental powder formula

Other: - Placebo Extensively Hydrolyzed Formula

placebo powder formula

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Hospital Colorado, Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Aurora, Colorado, 80045

Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Recruiting

Address

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329

UNC-Chapel Hill, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC-Chapel Hill

Chapel Hill, North Carolina, 27599

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Recruiting

Address

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

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