BridgeMD
New treatment option for Malnutrition (Calorie)
Official title Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
ClinicalTrials.gov ID: NCT07225153
What this study is testing
- What it's testing
- 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.
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 10
You may be able to join if
- 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...
- 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).
You likely can't join if
- 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 treatment trial.
- Who does not have access to goat milk in their households.
See the full eligibility 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
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Matiāri, Sindh, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 8 weeks to 10 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Matiāri, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.