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

This community-based randomized controlled trial will evaluate the safety, nutritional adequacy, and biological effects of a Goat Milk-Derived Formula Alternative (GMDFA) among infants aged 8-10 weeks in Matiari, Pakistan, who are unable to exclusively breastfeed. The study includes three groups: (1) an intervention group receiving GMDFA prepared according to a standardized recipe developed for the study, (2) a control group receiving undiluted goat milk according to local feeding practices, and (3) an active comparator group of exclusively breastfed infants serving as a reference. The intervention will last for 8 weeks. Primary and secondary outcomes will assess changes in lipidomic profiles, micronutrient status, gut inflammatory biomarkers (CRP, lipocalin-2, calprotectin, Claudin), and gut microbiome composition and diversity (Bifidobacterium, Firmicutes, Bacteroides, Clostridium, Lactobacillus). Anthropometric measurements including weight, length, and head circumference will be recorded at baseline and follow-up to evaluate infant growth outcomes. The study aims to determine whether GMDFA provides a safe and nutritionally appropriate alternative to formula milk for infants who cannot be exclusively breastfed, with comparable biological and growth outcomes to breastfed infants. Findings from this study will inform the potential use of goat milk-based alternatives in low-resource settings where malnutrition and suboptimal breastfeeding rates are prevalent.