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
• Infants aged = 08 -10 weeks with WAZ better than -1.8. (NIPS & ICF, 2019) Age Sex WAZ Weight in Kilograms 2 Month Boys WAZ>-1.8 4-5 kg 2 Month Girls WAZ>-1.8 4-5 kg Table 3: WAZ scores
Living in Matiari District.
Who has access to goat milk in their households.
The Breastfeeding group: Women who exclusively breastfeeding and not giving and sort of formula or animal derived milk.
• Infant birth weight < WAZ -1.8 i.e. weight-for-age based on established growth standards, such as the World Health Organization (WHO).
Birth deformities or disorders, such as genetic disorders, aerodigestive problems, or congenital anomalies.
Plan to migrate during the next six months.
We will exclude the women who exclusive breast feed and continue breast feeding for first 4 months.
Parallel
GMDFA
Dietary supplementGMDFA (GOat Milk-Derived Formula Alternative) is a goat milk-based formulation designed as an affordable alternative to commercial infant formula. It is prepared by diluting goat's milk to a standardized protein and micronutrient concentration according to study protocol. Infants in this arm will receive GMDFA from enrollment (08-10 weeks) until 16-18 weeks of age under close monitoring for growth and safety outcomes.
Undiluted Goat Milk
Other interventionInfants will receive undiluted goat milk as per current local feeding practices for 8 weeks.
Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups.
To evaluate whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive GMDFA show favorable changes in lipidomic profiles compared to those fed undiluted goat milk, and similar metabolic marker status compared to exclusively breastfed infants after 8 weeks of intervention.
Change in gut microbiome composition and diversity among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.
To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit distinct shifts in gut microbiome composition (Bifidobacterium, Firmicutes, Bacteroides, Clostridium, and Lactobacillus) and changes in alpha- and beta-diversity over 8 weeks, compared to those fed undiluted goat milk, and a microbiome profile similar to age-matched breastfed infants and healthy reference profiles from the same population.
Infant growth measured by weight-for-age z-score (WAZ)
Change in infant weight-for-age z-score from enrollment to 16-18 weeks of age, comparing GMDFA, breastfeeding, and undiluted goat milk groups.
Change in serum micronutrient levels among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.
To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit higher serum concentrations of essential micronutrients (vitamin A, vitamin B12, vitamin D, calcium, iron, and zinc) compared to those fed undiluted goat milk, and comparable micronutrient status to exclusively breastfed infants after 8 weeks of intervention.
Change in gut inflammatory biomarkers among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.
To assess whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) show favorable changes in gut inflammatory markers (CRP, Lipocalin-2, Claudin, and Calprotectin) compared to those fed undiluted goat milk, and similar gut inflammatory marker status to exclusively breastfed infants after 8 weeks of intervention.
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PakistanClick on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
Fogarty International Center of the National Institute of Health
Collaborator
University of Colorado, Boulder
Collaborator
Baker Heart Research Institute
Collaborator
