Dietary Restriction Efficiency Assessment in CMPA

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.

NCT Number	NCT07199023
Lead Sponsor	Ruijin Hospital Collaborators: Guangzhou Women and Children's Medical Center, Beijing Children's Hospital, Peking University Third Hospital, Guangdong Provincial People's Hospital, Chengdu Women's and Children's Central Hospital, Guiyang Maternity and Child Health Care Hospital
Conditions	Cow's Milk Protein Allergy
Enrollment	360 participants
Start Date	2026-01-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-11-17