An interventional study of GMDFA and Undiluted Goat Milk in Malnutrition (Calorie), Infant Nutrition Disorder and Growth Flatering, sponsored by Aga Khan University. Recruiting at 1 site in Pakistan. Open to participants aged 8 Weeks to 10 Weeks. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Aga Khan University · Not applicable, Interventional, and Prevention
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:
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.
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's planned enrollment of 15 is below the median of 118 across 843 interventional studies indexed under Malnutrition.
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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
Exclusion Criteria:
Infant birth weight \< WAZ -1.8 i.e. weight-for-age based on established growth standards, such as the World Health Organization (WHO).
Infants in this arm will receive Goat Milk-Derived Formula Alternative (GMDFA) as their primary source of feeding for 08 weeks. Growth, safety, and biological markers will be assessed through anthropometric measurements and laboratory analyses, including microbiome, metagenomic, and lipidomic profiling.
Dietary Supplement: GMDFA
Infants in this arm will receive undiluted goat milk according to local feeding practices, representing the current alternative to breastfeeding in the community. Growth and biological markers will be compared with the GMDFA and breastfed groups to evaluate safety and nutritional adequacy.
Other: Undiluted Goat Milk
Infants in this arm will be exclusively breastfed following WHO guidelines. No feeding intervention will be introduced. This group serves as the gold standard for comparison of growth metrics, microbiome composition, and metabolic biomarkers with the GMDFA and undiluted goat milk groups.
GMDFA (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.
Infants 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.
Time frame: Baseline (enrollment) to 8 weeks after 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.
Time frame: Baseline (enrollment) to 8 weeks after intervention
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.
Time frame: From baseline (enrollment) to 16-18 weeks of age
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.
Time frame: Baseline (enrollment) to 8 weeks after 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.
Time frame: Baseline (enrollment) to 8 weeks after intervention
Plan to share: Undecided
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