[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635182":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":31,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Dutch Medical Food","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional","ACTIVE_COMPARATOR",null,[13],"Other: Infant Formula",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","Infant Formula","Prospective, single-center, single-arm open label pilot study to show growth and tolerance in infants with\u002Fat risk of FG\u002FFTT when fed an ENDF for 8 weeks.",[9],[21],"Energy and Nutrient Dense Infant Formula (ENDF)",[23,29],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},"Chonnikant Visuthranukul, MD, PhD","CONTACT","+66 2256 4000","4903","deknet@gmail.com",{"name":30,"role":25,"phone":11,"phoneExt":11,"email":11},"Eakkarin Mekangkul, MD",[32],{"facility":33,"status":11,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Department of Pediatrics, Faculty of Medicine, Chulalongkorn University","Bangkok","10330","Thailand","TH",{"type":39,"coordinates":40},"Point",[41,42],100.50144,13.75398,{"lat":42,"lon":41},[45],{"name":24,"role":25,"phone":26,"phoneExt":27,"email":28},{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100635182","leveraging-optimal-tolerance-in-undernourished-infants-to-support-growth-100635182",false,"NCT07549360","Leveraging Optimal Tolerance in Undernourished Infants to Support Growth","LOTUS","Inclusion Criteria:\n\n* Infants aged from 1 month to \\\u003C\u002F=12 months of age\n* Infants taking at least 50% of daily intake from infant formula\n* Diagnosis of FG (a fall in WAZ of ≥1.0 SD over 1 month or more - not including the first 2 weeks after birth) or risk of FG (static weight for \\>\u002F= 1 month)\n* Infants \\>\u002F=37 weeks gestation at time of recruitment\n* Parent\u002F legal guardian willing to provide written informed consent\n\nExclusion Criteria:\n\n* Exclusively Breastfed infants\n* Infants with other medical problems that might independently affect intake (oral or otherwise) or who have specific nutrient needs not met by IC e.g. some gastrointestinal malformations, some renal and liver conditions, inborn errors of metabolism, galactosemia\n* Infants on total parenteral nutrition\n* Infants with cow milk protein allergy\n* Infants with soy allergy\n* Infants who participated in other studies within 2 weeks prior to recruitment\n* Situations where the investigator has concerns about the willingness or ability of the parents\u002Fcaregivers to comply with protocol requirements\n* Infants who are on a vegan diet\n* Infants who are allergic to fish\n* Infants born preterm \\\u003C37 weeks gestation","ALL","1 Month","12 Months",{"count":59,"type":60},35,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.",[66,67],"Faltering Growth","Failure to Thrive",[66,67,69,53,70],"Energy and Nutrient Dense Formula","Infacore","NOT_YET_RECRUITING","2026-04-18",{"date":74,"type":75},"2026-04-24","ACTUAL",{"date":77,"type":60},"2026-05-15",{"date":79,"type":60},"2027-05-15",{"name":5,"class":6},1]