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

NCT06456541 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-05-13

No results posted yet for this 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

  • Cow's Milk Allergy

Interventions

OTHER

Experimental Extensively Hydrolyzed Formula

Experimental powder formula

OTHER

Placebo Extensively Hydrolyzed Formula

Placebo powder formula

Sponsors & Collaborators

  • Abbott Nutrition

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-07-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06456541 on ClinicalTrials.gov