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Hydrolyzed Formula in Infants and Children with Cow's Milk Allergy

To qualify an extensively hydrolyzed casein-based infant formula as hypoallergenic according to the standards published by the American Academy of Pediatrics.

I'm interested

Age & Gender

3 months ~ 12 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide), South Carolina, Virginia

What will be asked of you

1. Researchers will confirm your child has a cow's milk allergy, according to study criteria. 2. Your child will participate in two food challenge tests (one of the study formula and one of the placebo formula). 3. Your child will be asked to consume the experimental formula for seven days. You will record information about your child's consumption of the formula in a study diary. 4. Participants who complete #1-3 above can continue an additional 6 months of feeding, during which the test formula will be supplied at no cost to the participant. This part of the study is optional.

Incentives

Information Provided Upon Request, Parking Vouchers

In-person visits:
3-4

Phone or online visits:
1-4

Total length of participation:
2 months

Looking for Specific Volunteers

Able to participate:

Child has cow's milk allergy
Child has followed a strict cow's milk protein-free diet for at least 2 weeks prior to enrollment
Child will not be given any cow's milk protein containing products while in the study

Not eligible if:

Child is consuming baked milk products
Child is consuming breast milk
FPIAP
FPIES

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lauren Herlihy
foodallergy@unc.edu

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Edwin Kim
Medicine-UNCP A Allergy and Immunology

Study Type

Clinical or Medical
Interventional

Study Topics

Allergy

IRB Number

24-0634

ClinicalTrials.gov

NCT06456541

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Questions?

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