Growth Flatering, Gut Microbiome, Infant Nutrition Disorder, Lipidomics, Malnutrition (Calorie)
Conditions
Keywords
Infant nutrition, goat milk, Infant feeding practices, Breastfeeding, Breastfeeding Alternatives, Alternate feeding practices, Growth outcomes, Infant growth metrics, Gut microbiome, Gut inflammation biomarkers, Calprotectin, Lipocalin-2, Claudin-2, C-reactive protein (CRP), Randomized controlled trial, Rural Pakistan, Infant health, Malnutrition prevention, Lipidomics, Breast milk, Metagenomics
Brief 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
Detailed description
This community-based randomized controlled trial will evaluate the safety, nutritional adequacy, and biological effects of a Goat Milk-Derived Formula Alternative (GMDFA) among infants aged 8-10 weeks in Matiari, Pakistan, who are unable to exclusively breastfeed. The study includes three groups: (1) an intervention group receiving GMDFA prepared according to a standardized recipe developed for the study, (2) a control group receiving undiluted goat milk according to local feeding practices, and (3) an active comparator group of exclusively breastfed infants serving as a reference. 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.
Interventions
DIETARY_SUPPLEMENTGMDFA
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.
OTHERUndiluted Goat Milk
Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.
Sponsors
Aga Khan University
Fogarty International Center of the National Institute of Health
University of Colorado, Boulder
Baker Heart Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label trial due to the visible differences between feeding interventions (GMDFA, undiluted goat milk, and breastfeeding). Participants, caregivers, and field investigators will be aware of group assignments. 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.
Intervention model description
This is a three-arm, parallel-group, community-based randomized controlled trial designed to compare the effects of Goat Milk-Derived Formula Alternative (GMDFA), undiluted goat milk, and exclusive breastfeeding on infant growth, gut microbiome, and metabolic health. Infants will be randomly assigned to one of the three groups and followed concurrently for a 8-week intervention period. Each group will receive its assigned feeding regimen in parallel, with no crossover between groups.
Eligibility
Sex/Gender
ALL
Age
8 Weeks to 10 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in lipidomic markers among infants receiving Goat Milk-Derived Formula Alternative (GMDFA) compared to undiluted goat milk and breastfeeding groups. | Baseline (enrollment) to 8 weeks after intervention | To evaluate whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive GMDFA show favorable changes in lipidomic profiles compared to those fed undiluted goat milk, and similar metabolic marker status compared to exclusively breastfed infants after 8 weeks of intervention. |
| Change in gut microbiome composition and diversity among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. | Baseline (enrollment) to 8 weeks after intervention | To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit distinct shifts in gut microbiome composition (Bifidobacterium, Firmicutes, Bacteroides, Clostridium, and Lactobacillus) and changes in alpha- and beta-diversity over 8 weeks, compared to those fed undiluted goat milk, and a microbiome profile similar to age-matched breastfed infants and healthy reference profiles from the same population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant growth measured by weight-for-age z-score (WAZ) | From baseline (enrollment) to 16-18 weeks of age | Change in infant weight-for-age z-score from enrollment to 16-18 weeks of age, comparing GMDFA, breastfeeding, and undiluted goat milk groups. |
| Change in serum micronutrient levels among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. | Baseline (enrollment) to 8 weeks after intervention | To determine whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) exhibit higher serum concentrations of essential micronutrients (vitamin A, vitamin B12, vitamin D, calcium, iron, and zinc) compared to those fed undiluted goat milk, and comparable micronutrient status to exclusively breastfed infants after 8 weeks of intervention. |
| Change in gut inflammatory biomarkers among infants receiving GMDFA compared to undiluted goat milk and breastfeeding groups. | Baseline (enrollment) to 8 weeks after intervention | To assess whether infants aged 8-10 weeks in Matiari who are unable to exclusively breastfeed and receive Goat Milk-Derived Formula Alternative (GMDFA) show favorable changes in gut inflammatory markers (CRP, Lipocalin-2, Claudin, and Calprotectin) compared to those fed undiluted goat milk, and similar gut inflammatory marker status to exclusively breastfed infants after 8 weeks of intervention. |
Countries
Pakistan
Contacts
CONTACTNimra Mazhar, M.Phil
PRINCIPAL_INVESTIGATORDr. junaid Iqbal, PhD
Aga Khan University
STUDY_DIRECTORSyed Asad Ali, MPH
Aga Khan University
Outcome results
None listed