[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wuqu' Kawoq, Maya Health Alliance\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100654880","pilot-study-of-a-modified-therapeutic-food-compared-with-a-standard-nutrient-supplement-in-young-children-in-rural-guatemala-100654880",false,"NCT07804667","Pilot Study of a Modified Therapeutic Food Compared With a Standard Nutrient Supplement in Young Children in Rural Guatemala","A Pilot Study to Evaluate the Acceptability, Tolerability, and Short-Term Biological Signals of a Modified Therapeutic Food Compared to a Standard Lipid-Based Nutrient Supplement in Children Aged 12-24 Months in Rural Guatemala","Inclusion Criteria:\n\n* Children aged 12 to 24 months at enrollment\n* Mild-to-moderate stunting, defined as height-for-age Z-score (HAZ) less than -1 and greater than -3\n* Primary caregiver willing and able to provide informed consent\n* Caregiver has access to a phone or WhatsApp, or has a trusted proxy such as a family member or neighbor who can assist with phone calls or WhatsApp communication\n\nExclusion Criteria:\n\n* Moderate or severe acute malnutrition, defined as weight-for-height Z-score (WHZ) less than -2\n* Antibiotic use within the preceding 14 days\n* Known food allergy or intolerance to study ingredients, including peanut, dairy, or egg\n* History of persistent diarrhea, defined as watery stools lasting more than 7 consecutive days within the past month\n* Caregiver report of frequent or severe abdominal distension or pain occurring shortly after consumption of fiber-rich foods","ALL","12 Months","24 Months",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether a modified food supplement is acceptable and well tolerated by children aged 12 to 24 months with mild-to-moderate stunting in rural Guatemala. The study will also explore whether the food is associated with short-term changes in stool markers related to gut inflammation and microbial activity.\n\nThe main questions are:\n\n* Will children accept and regularly eat the modified food supplement?\n* What stomach or bowel symptoms, if any, occur while children eat the supplement?\n* Do stool markers related to gut health change over the short study period?\n\nResearchers will compare the modified food supplement with Nutri Listo, a small-quantity lipid-based nutrient supplement already used in Guatemala. Children will be assigned by chance to one of the two groups.\n\nParticipants will:\n\n* Complete a brief taste and acceptability test\n* Eat one 30-gram sachet of the assigned food each day for 21 days\n* Have their caregiver receive brief phone or WhatsApp check-ins during the study\n* Provide a stool sample near the beginning and end of the study\n\nThis is a small pilot study. It is designed to assess feasibility, acceptability, tolerability, and early biological signals rather than to determine whether the modified food improves growth or other clinical outcomes.",[27,28],"Stunting of Growth","Chronic Malnutrition",[30,31,32,33,34,35],"Childhood stunting","Therapeutic food","Small-quantity lipid-based nutrient supplement","Gut microbiome","Environmental enteric dysfunction","Guatemala","NOT_YET_RECRUITING","2026-08-31",{"date":39,"type":40},"2026-09-04","ACTUAL",{"date":42,"type":21},"2026-09-15",{"date":44,"type":21},"2026-11-30",{"name":46,"class":47},"Wuqu' Kawoq, Maya Health Alliance","OTHER",""]