Status:
NOT_YET_RECRUITING
Dietary Restriction Efficiency Assessment in CMPA
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Guangzhou Women and Children's Medical Center
Beijing Children's Hospital
Conditions:
Cow's Milk Protein Allergy
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief 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 alle...
Detailed Description
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with a prevalence of approximately 2.5-3.0% globally and 0.83-3.5% in China. Accurate diagnosis is often challeng...
Eligibility Criteria
Inclusion
- Infants aged 0-6 months; Diagnosed with suspected CMPA at the time of presentation; Artificially or mixed-feeding; Parents willing to sign a written informed consent and comply with the study protocol.
Exclusion
- Infants currently receiving eHF or AAF formula; Mixed-feeding infants whose current daily formula intake is less than 50% of their total milk intake or less than 200 ml; Infants who have already started adding complementary foods; Infants who have experienced severe food allergy symptoms such as shock, severe vomiting, etc. after taking cow's milk protein; Infants with clinical manifestations of systemic allergic reaction or respiratory difficulties such as acute laryngeal edema or bronchial obstruction; Infants who have used prednisolone or anti-allergic drugs in the past 2 weeks; Infants with contraindications to eHF or AAF formula; Infants whose parents are unable to fully report the occurrence of possible symptoms (e.g., insufficient language skills); Infants with other serious diseases, including but not limited to growth retardation, metabolic disorders, kidney disease, congenital heart disease, medical conditions requiring hospitalization for more than 2 weeks, etc.; Infants whose mothers are unable to avoid necessary foods when mixed-feeding.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT07199023
Start Date
January 1 2026
End Date
December 31 2027
Last Update
November 17 2025
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