Impact of Partially Hydrolyzed Whey-based Infant Formulas on Growth and Digestive Comfort in Healthy Full-Term Infants A Randomized, Double-Blind, Controlled Study

What this Trial Is About

Researchers are studying how different partially hydrolyzed, whey-based infant formulas affect growth and digestive comfort in healthy full-term infants. This is a randomized, controlled trial comparing two experimental formulas made with hydrolyzed protein to a control formula containing intact protein. The study aims to understand how these formulas influence infant growth over the first four months and their gastrointestinal tolerance. Participants will receive one of three infant formulas a control formula with intact protein, Experimental Formula 1 with hydrolyzed protein, or Experimental Formula 2 also with hydrolyzed protein but produced using a different milk protein base. These formulas differ slightly in protein content and processing. The study follows infants from enrollment until they reach 4 months of age to assess growth differences and equivalence, while also monitoring for tolerance. During the study, researchers will monitor participants growth through measurements like weight, length, and head circumference at various ages up to 6 months. They will also assess gastrointestinal tolerance, stool patterns, allergy symptoms, and dietary intake through scheduled visits. The primary outcomes focus on growth during the first 4 months. This trial includes regular assessments to track infants health, development, and any allergic or digestive symptoms during their first year.

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants