Goat milk–derived formula versus undiluted goat milk for infants who cannot be exclusively breastfed: growth and gut health
Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers
This study will test whether a goat milk–derived formula is safe and supports similar growth and gut health for 8–10 week old infants who cannot be exclusively breastfed, compared with undiluted goat milk or breast milk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 8 Weeks to 10 Weeks |
| Sex | All |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Matiāri, Sindh) |
| Trial ID | NCT07225153 on ClinicalTrials.gov |
What this trial studies
This is a community-based randomized controlled trial in Matiari, Pakistan enrolling infants aged 8–10 weeks with weight-for-age (WAZ) better than -1.8. Participants are randomized to one of three arms for 8 weeks: a standardized goat milk–derived formula alternative (GMDFA), undiluted goat milk given per local practice, or exclusive breastfeeding as a reference group. Outcomes include anthropometric measurements (weight, length, head circumference), lipidomic and micronutrient profiles, and gut inflammatory biomarkers (CRP, lipocalin-2, calprotectin, claudin), together with gut microbiome composition and metabolic pathway analyses. The trial aims to compare nutritional adequacy, safety, and biological impacts of GMDFA against local goat milk feeding and breastfeeding in a low-resource setting.
Who should consider this trial
Good fit: Infants aged 8–10 weeks living in Matiari District with WAZ > -1.8 who are unable to be exclusively breastfed and whose households have access to goat milk are the intended participants.
Not a fit: Infants with low weight-for-age (WAZ ≤ -1.8), congenital anomalies or aerodigestive disorders, or families planning to migrate are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, GMDFA could offer a safe, nutritionally appropriate alternative for infants who cannot be exclusively breastfed, potentially improving growth and gut health in low-resource communities.
How similar studies have performed: Prior research on goat-milk–based infant formulas shows some comparable growth and tolerability to cow-milk formulas, but high-quality randomized data comparing goat-milk formulas with undiluted goat milk and breast milk in low-resource settings are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Matiāri, Sindh
- MATIARI Research & Training Centre — Matiāri, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr. junaid Iqbal, PhD — Aga Khan University
- Study coordinator: Nimra Mazhar, M.Phil
- Email: nimra.mazhar@scholar.aku.edu
- Phone: +923012354157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.