[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610251":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":69,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":28,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":24,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Aga Khan University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Goat Milk-Derived Formula Alternative (GMDFA)","EXPERIMENTAL","Infants in this arm will receive Goat Milk-Derived Formula Alternative (GMDFA) as their primary source of feeding for 08 weeks. Growth, safety, and biological markers will be assessed through anthropometric measurements and laboratory analyses, including microbiome, metagenomic, and lipidomic profiling.",[13],"Dietary Supplement: GMDFA",{"label":15,"type":16,"description":17,"interventionNames":18},"Undiluted Goat Milk (Current Practice)","ACTIVE_COMPARATOR","Infants in this arm will receive undiluted goat milk according to local feeding practices, representing the current alternative to breastfeeding in the community. Growth and biological markers will be compared with the GMDFA and breastfed groups to evaluate safety and nutritional adequacy.",[19],"Other: Undiluted Goat Milk",{"label":21,"type":22,"description":23,"interventionNames":24},"Breastfed Group (Reference Comparator)","NO_INTERVENTION","Infants in this arm will be exclusively breastfed following WHO guidelines. No feeding intervention will be introduced. This group serves as the gold standard for comparison of growth metrics, microbiome composition, and metabolic biomarkers with the GMDFA and undiluted goat milk groups.",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"DIETARY_SUPPLEMENT","GMDFA","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.",[9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"Undiluted Goat Milk","Infants will receive undiluted goat milk as per current local feeding practices for 8 weeks.",[15],[36,39],{"name":37,"affiliation":5,"role":38},"Dr. junaid Iqbal, PhD","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":5,"role":41},"Syed Asad Ali, MPH","STUDY_DIRECTOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":24,"email":47},"Nimra Mazhar, M.Phil","CONTACT","+923012354157","nimra.mazhar@scholar.aku.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":24,"geoPoint":24,"contacts":57},"MATIARI Research & Training Centre","RECRUITING","Matiāri","Sindh","45330","Pakistan","PK",[58,62],{"name":59,"role":45,"phone":60,"phoneExt":24,"email":61},"Dr. Fayyaz Umrani, MSPH","+923337009960","fayaz.umrani@aku.edu",{"name":63,"role":45,"phone":64,"phoneExt":24,"email":65},"Dr. Sheraz Ahmed","+923343131087","sheraz.ahmed@aku.edu",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Junaid Iqbal","Assistant Professor Research",[70,73,75],{"name":71,"class":72},"Fogarty International Center of the National Institute of Health","NIH",{"name":74,"class":6},"University of Colorado, Boulder",{"name":76,"class":6},"Baker Heart Research Institute","100610251","goat-milk-derived-formula-vs-undiluted-goat-milk-in-infants-unable-to-exclusively-breastfeed-growth-and-biomarker-analysis-100610251",false,"NCT07225153","Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis","Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers","Inclusion Criteria:\n\n* • 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\n\n  * Living in Matiari District.\n  * Who has access to goat milk in their households.\n  * The Breastfeeding group: Women who exclusively breastfeeding and not giving and sort of formula or animal derived milk.\n  * Intervention Group: Women who do not breastfeed at all or give goat milk to their infants (2-3 feeds per day).\n  * No birth deformities\n\nExclusion Criteria:\n\n* • Infant birth weight \\\u003C WAZ -1.8 i.e. weight-for-age based on established growth standards, such as the World Health Organization (WHO).\n\n  * Birth deformities or disorders, such as genetic disorders, aerodigestive problems, or congenital anomalies.\n  * Plan to migrate during the next six months.\n  * We will exclude the women who exclusive breast feed and continue breast feeding for first 4 months.\n  * If the child is enrolled or included in any other interventional trial.\n  * Who does not have access to goat milk in their households.\n  * 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","ALL","8 Weeks","10 Weeks",{"count":88,"type":89},15,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.\n\nThe main questions it aims to answer are:\n\n1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed?\n2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups?\n3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles?\n4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed?\n\nWe will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes.\n\nParticipants will:\n\nBe randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed\n\nAttend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable)\n\nHave feeding practices monitored and recorded through caregiver interviews and feeding logs\n\nAdditional Analyses:\n\nMicrobiome 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",[95,96,97,98,99],"Malnutrition (Calorie)","Infant Nutrition Disorder","Growth Flatering","Gut Microbiome","Lipidomics",[101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,99,119,120],"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","Breast milk","Metagenomics","2026-03-25",{"date":123,"type":124},"2026-03-30","ACTUAL",{"date":126,"type":124},"2025-08-30",{"date":128,"type":89},"2026-03-18",{"name":5,"class":6},1]