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Dietary Restriction Efficiency Assessment in CMPA
Sponsor: Ruijin Hospital
Summary
This clinical trial aims to evaluate and compare the efficacy of amino acid formula (AAF) and extensively hydrolyzed formula (eHF) in relieving symptoms in infants suspected of cow's milk protein allergy (CMPA) during the diagnostic elimination diet phase. The study will also assess treatment compliance, economic costs, and develop a CMPA screening score suitable for Chinese infants. Eligible infants (0-6 months old) will be randomized to receive either AAF or eHF for at least 2 weeks. Symptom improvement will be evaluated, followed by an oral food challenge (OFC) to confirm CMPA diagnosis. Infants in the eHF group who do not improve may switch to AAF for further evaluation. The total duration of participation is approximately 6 to 8 weeks. The study aims to provide evidence-based data to optimize diagnostic pathways and improve quality of life for infants with CMPA.
Official title: Dietary Restriction Efficiency Assessment of Different Hypoallergenic Formulas in Patients With Suspected Cow's Milk Protein Allergy
Key Details
Gender
All
Age Range
0 Months - 6 Months
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2025-11-17
Healthy Volunteers
No
Conditions
Interventions
Amino Acid Formula (AAF)
A formula composed of 100% free amino acids with no intact cow's milk protein. Participants will be fed AAF ad libitum according to their nutritional needs. Daily intake and symptoms will be recorded through an electronic diary (eCOA).
Extensively Hydrolyzed Formula (eHF)
A formula in which cow's milk proteins are broken down into small peptides through enzymatic hydrolysis, reducing allergenicity. Participants will be fed eHF ad libitum based on their nutritional needs. Intake and symptoms will be tracked through an electronic diary (eCOA).