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

Summary

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

Conditions

• Malnutrition (Calorie)
• Infant Nutrition Disorder
• Growth Flatering
• Gut Microbiome
• Lipidomics

Interventions

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.

OTHER

Undiluted Goat Milk

Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.

Sponsors & Collaborators

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• University of Colorado, Boulder

  collaborator OTHER

• Baker Heart Research Institute

  collaborator OTHER

• Aga Khan University

  lead OTHER

Principal Investigators

• Dr. junaid Iqbal, PhD · Aga Khan University

• Syed Asad Ali, MPH · Aga Khan University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Weeks

Max Age

10 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-30

Primary Completion

2025-12-30

Completion

2026-03-18

Countries

• Pakistan