Study Comparing Goat Milk-Based Formula, Undiluted Goat Milk, and Breastfeeding for Infants 8-10 Weeks Old Assessing Growth, Gut Health, and Safety

What this Trial Is About

Researchers are evaluating the safety and nutritional adequacy of a Goat Milk-Derived Formula Alternative GMDFA for infants aged 8 to 10 weeks who cannot be exclusively breastfed. The study compares growth, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The goal is to see if GMDFA supports similar growth patterns and gut health as breastfeeding, especially in low-resource settings with malnutrition concerns. Participants are randomly assigned to one of three groups those fed GMDFA made to a standardized recipe for 8 weeks, those fed undiluted goat milk following local practices for 8 weeks, and a reference group of exclusively breastfed infants. The study carefully monitors infant growth and collects samples of blood, stool, and breast milk where applicable to analyze microbiome diversity, metabolic pathways, and lipid profiles. During the study, infants will have regular follow-up visits for growth measurements and biological sample collection. Feeding practices will be tracked through caregiver interviews and feeding logs. Researchers will measure changes in lipidomic markers and gut microbiome composition from baseline to 8 weeks after intervention, as well as growth by weight-for-age z-score up to 16-18 weeks of age. Safety and nutritional biomarkers will also be assessed to ensure the feeding options are appropriate.

Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis