360
Participants
Start Date
October 1, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
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).
Guangzhou Women and Children's Medical Center
OTHER
Beijing Children's Hospital
OTHER
Peking University Third Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Chengdu Women's and Children's Central Hospital
OTHER
Guiyang Maternity and Child Health Care Hospital
OTHER
Ruijin Hospital
OTHER