Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy

This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based formula in infants with cow's milk protein allergy. After a confirmation of the diagnostic, this demonstration will be performed with oral food challenge. Secondarily, a long term tolerance phase will be performed to get growth outcomes with a consumption of the formula compared with a non-enriched formula.

NCT Number	NCT07592182
Lead Sponsor	Lactalis
Conditions	Cow Milk Protein Allergy, FPIES
Enrollment	55 participants
Start Date	2026-05
Primary Completion	2028-03 (estimated)
Study Completion	2028-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-26