Goat milk–derived formula versus undiluted goat milk for infants who cannot be exclusively breastfed: growth and gut health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.