Novel Infant Formula Randomized Trial, Ages 12-18 Months

NIH published a clinical trial registration on ClinicalTrials.gov for a randomized, controlled, three-arm study investigating investigational infant formulas in healthy infants and young children aged 12-18 months. The trial will assess growth, gut health, immune function, and sleep outcomes. Two investigational formulas will be evaluated against a control.\n\nThis is an informational registration with no compliance obligations for third parties. Pharmaceutical companies, contract research organizations, and clinical investigators conducting the study will be subject to FDA IND/IDE regulations and ICH/GCP standards for trial conduct and adverse event reporting.