Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination
Partially Hydrolyzed Formula in Cow's Milk Protein Allergy After 6 Months of Elimination
NCT ID: NCT06130085 Phase: NA Status: COMPLETED Enrollment: 100 Completion: 2025-03-28
Conditions
Cow's Milk Protein Allergy
Interventions
Partially hydrolyzed formula
Summary
For Patients diagnosed as cow milk protein allergy: Elimination of cow's milk products (CMPs) for 6 months.
All infants were supplemented with Amino Acid-based Formula (AAF) (Neocate infant®/ Neocate junior®, Dannone Nutricia) for 6 months at start of elimination diet.
For mixed milk fed infants (still receiving breast milk with the formula), mothers were encouraged to continue breast-feeding while avoiding all milk and milk products from their own diet.
Intervention after completing 6 months of eliminating CMPs. The included patients were randomly assigned to one of (2 groups).
- Group I (AAF group) n= 50 Infants in this group continued with Amino Acid-based Formula for another 6 months.
- Group II (pHF group) n= 50 Infants in this group were shifted gradually to Partially-hydrolyzed whey formula (pHF) (Liptomil Plus HA infant formula. for another 6 months with continuation of elimination of cow's milk products.
They were followed up for manifestations of intolerance to pHF. Infant who showed manifestations of intolerance were returned to AAF and continued for 6 months with AAF.
Final step: Reintoduction of CMPs After 12 months of elimination of CMPs, evaluation of tolerance to whole CMPs was done by oral food challenge (OFC).
For infants who were still non-tolerant to CMPs after 12 months of elimination were followed up and re-challenged after 6 months.
Primary Outcome
compare the rate of tolerance to cow milk products among patients allocated to partially hydrolyzed formula after 6 months of milk free diet compared to those who completed 1 year of elimination