NCT06456541 · Abbott Nutrition
Infant Formula in Infants and Children With Cow's Milk Allergy
What this study is about
This is a multi-center, randomly assigned, double-blinded, compared against an inactive treatment 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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;
- Documentation of milk-specific serum IgE \>15 kUᴀ/L or \> 5 kUᴀ/L if younger than 1 year;
- Documented cow's milk skin prick test wheal \>10mm;
- 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 prior to 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, eczema and/or food allergies 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.
- Use of and/or changing dose of high potency steroids.
Where
- Phoenix, Arizona
- Aurora, Colorado
- Chicago, Illinois
- Ann Arbor, Michigan
- Chapel Hill, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations