Study of Hydrolyzed Rice Protein Formula on Growth and Health in Infants With Cows Milk Protein Allergy

What this Trial Is About

Researchers are evaluating the growth, gastrointestinal tolerance, quality of life, and acceptability of a new hydrolyzed rice protein-based formula in infants diagnosed with cows milk protein allergy CMPA. The study aims to show that infants fed the new Test Formula grow as well as those fed a Control Formula made of extensively hydrolyzed cows milk protein. The trial is a randomized nutritional clinical study involving infants with CMPA. Participants will receive either the Test Formula hydrolyzed rice protein formula or the Control Formula commercially available extensively hydrolyzed cows milk formula. The study follows the infants for 4 months after enrollment, assessing growth and health-related outcomes during this period. During the study, infants will be monitored monthly for weight, length, gastrointestinal symptoms, and cows milk allergy-related symptoms. Additional measurements include head circumference, tibia and femur length, stool frequency and consistency, quality of life assessments, formula compliance, and safety monitoring for adverse events. The primary outcome measure is the weight-for-age z-score at 4 months post-enrollment.

Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.