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

Aga Khan University

Status: Enrolling

Conditions: Gut Microbiome; Infant Nutrition Disorder; Lipidomics; Malnutrition (Calorie); Growth Flatering

Treatments: Other: Undiluted Goat Milk; Dietary Supplement: GMDFA

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07225153

D43TW007585 (U.S. NIH Grant/Contract)

2025-11220-34303

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 8 to 10 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • 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.
  • Intervention Group: Women who do not breastfeed at all or give goat milk to their infants (2-3 feeds per day).
  • No birth deformities

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).

  • 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.
  • If the child is enrolled or included in any other interventional trial.
  • Who does not have access to goat milk in their households.
  • Are medically disqualified: Any potential participant who is deemed medically unfit for enrollment, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Goat Milk-Derived Formula Alternative (GMDFA)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: GMDFA

Undiluted Goat Milk (Current Practice)

Active Comparator group

Description:

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.

Treatment:

Other: Undiluted Goat Milk

Breastfed Group (Reference Comparator)

No Intervention group

Description:

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.