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

Overview

The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed. It will also study growth patterns, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk. The main questions it aims to answer are: 1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed? 2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups? 3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles? 4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed? We will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes. Participants will: Be randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed Attend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable) Have feeding practices monitored and recorded through caregiver interviews and feeding logs Additional Analyses: Microbiome analysis: to identify gut bacterial diversity and composition across feeding groups Metagenomic analysis: to explore functional genes and metabolic pathways related to nutrition and gut health Lipidomic analysis: to assess differences in lipid and fatty acid profiles in breast milk, goat milk, and infant samples

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.