RecruitingNot Applicable

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

Pakistan15 participantsStarted 2025-08-30

Plain-language 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

Who can participate

Age range8 Weeks – 10 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups.

Timeframe: 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.

Timeframe: Baseline (enrollment) to 8 weeks after intervention

Trial details

NCT IDNCT07225153

SponsorAga Khan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Nimra Mazhar, M.Phil

+923012354157 nimra.mazhar@scholar.aku.edu

View on ClinicalTrials.gov More Malnutrition (Calorie) trials

Plain-language summary

Who can participate

Age range8 Weeks – 10 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups.

Timeframe: 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.

Timeframe: Baseline (enrollment) to 8 weeks after intervention