Actively Recruiting
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
Led by Aga Khan University · Updated on 2026-03-30
15
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
Sponsors
A
Aga Khan University
Lead Sponsor
F
Fogarty International Center of the National Institute of Health
Collaborating Sponsor
AI-Summary
What this Trial Is 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
CONDITIONS
Official Title
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 8 to 10 weeks with weight-for-age Z-score (WAZ) better than -1.8 (approximately 4-5 kg for boys and girls)
- Living in Matiari District
- Access to goat milk in their households
- Breastfeeding group: Infants exclusively breastfed without any formula or animal-derived milk
- Intervention group: Infants not breastfed or fed goat milk 2-3 times per day
- No birth deformities
You will not qualify if you...
- Infant birth weight with WAZ less than -1.8
- Birth deformities or disorders such as genetic disorders, aerodigestive problems, or congenital anomalies
- Plan to migrate within the next six months
- Mothers who exclusively breastfeed for the first 4 months
- Participation in any other interventional trial
- No access to goat milk in household
- Medically unfit due to severe or unstable health conditions that could compromise safety or study outcomes
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MATIARI Research & Training Centre
Matiāri, Sindh, Pakistan, 45330
Actively Recruiting
Research Team
N
Nimra Mazhar, M.Phil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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