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

March 25, 2026 updated by: Junaid Iqbal, Aga Khan University

Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Matiāri, Sindh, Pakistan, 45330
        • Recruiting
        • MATIARI Research & Training Centre
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Goat Milk-Derived Formula Alternative (GMDFA)
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
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.
Active Comparator: Undiluted Goat Milk (Current Practice)
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 will receive undiluted goat milk as per current local feeding practices for 8 weeks.
No Intervention: Breastfed Group (Reference Comparator)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups.
Time Frame: Baseline (enrollment) to 8 weeks after intervention
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.
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.
Time Frame: Baseline (enrollment) to 8 weeks after intervention
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.
Baseline (enrollment) to 8 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant growth measured by weight-for-age z-score (WAZ)
Time Frame: From baseline (enrollment) to 16-18 weeks of age
Change in infant weight-for-age z-score from enrollment to 16-18 weeks of age, comparing GMDFA, breastfeeding, and undiluted goat milk groups.
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.
Time Frame: Baseline (enrollment) to 8 weeks after intervention
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.
Baseline (enrollment) to 8 weeks after intervention
Change in gut inflammatory biomarkers among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups.
Time Frame: Baseline (enrollment) to 8 weeks after intervention
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.
Baseline (enrollment) to 8 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Fogarty International Center of the National Institute of Health
University of Colorado, Boulder
Baker Heart Research Institute

Investigators

  • Principal Investigator: Dr. junaid Iqbal, PhD, Aga Khan University
  • Study Director: Syed Asad Ali, MPH, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Estimated)

March 18, 2026

Study Registration Dates

First Submitted

November 4, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-11220-34303
  • D43TW007585 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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