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

Study Purpose

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 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'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.

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.	NCT06456541
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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
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 Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Kristen DeLuca

[email protected]

6145653522

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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