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Infant Formula in Infants and Children With Cow's Milk Allergy
NCT06456541 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Experimental Extensively Hydrolyzed Formula
- OTHER Placebo Extensively Hydrolyzed Formula
Study Locations (8)
Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Cleveland Clinic — Cleveland
- Nationwide Children's Hospital — Columbus
Colorado
- Children's Hospital Colorado — Aurora
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Michigan
- University of Michigan Food Allergy Clinic — Ann Arbor
North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill
Texas
- UT Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2029-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06456541
The ClinicalTrials.gov registry entry for NCT06456541 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Nutrition, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cow's Milk Allergy appearing as the primary indexed condition, and to 2 interventions — of which Experimental Extensively Hydrolyzed Formula is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06456541 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Ohio, Colorado, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06456541 about?
NCT06456541 is a clinical study titled "Infant Formula in Infants and Children With Cow's Milk Allergy". 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.
What is the current status of trial NCT06456541?
This trial is currently recruiting. It is a NA study. The enrollment target is 61 participants. The study started on 2024-10-01. Estimated completion is 2029-01.
What conditions does trial NCT06456541 study?
This clinical trial studies the following conditions: Cow's Milk Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06456541?
The interventions under investigation include: Experimental Extensively Hydrolyzed Formula (OTHER), Placebo Extensively Hydrolyzed Formula (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06456541?
This trial is sponsored by Abbott Nutrition, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06456541 being conducted?
This trial has 8 study locations across Colorado, Illinois, Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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