Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
NCT ID: NCT07225153
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2025-08-30
2026-02-01
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
However, to reduce potential bias, laboratory personnel conducting the microbiome, metagenomic, and lipidomic analyses will remain blinded to the feeding group assignments throughout sample processing and data analysis.
Study Groups
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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.
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.
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.
Undiluted Goat Milk
Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.
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.
No interventions assigned to this group
Interventions
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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.
Undiluted Goat Milk
Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Weeks
10 Weeks
ALL
No
Sponsors
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Fogarty International Center of the National Institute of Health
NIH
University of Colorado, Boulder
OTHER
Baker Heart Research Institute
OTHER
Aga Khan University
OTHER
Responsible Party
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Junaid Iqbal
Assistant Professor Research
Principal Investigators
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Dr. junaid Iqbal, PhD
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University
Syed Asad Ali, MPH
Role: STUDY_DIRECTOR
Aga Khan University
Locations
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MATIARI Research & Training Centre
Matiāri, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Dr. Fayyaz Umrani, MSPH
Role: primary
Dr. Sheraz Ahmed
Role: backup
References
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Other Identifiers
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2025-11220-34303
Identifier Type: -
Identifier Source: org_study_id