[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526612":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":43,"interventions":56,"overallOfficials":69,"centralContacts":73,"locations":82,"responsibleParty":104,"collaborators":108,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":32,"studyType":125,"phases":126,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":85,"whyStopped":32,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":32},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Daily Stool Frequency","Number of bowel movements (BMs) per day (count)","Up to 14 days",{"measure":14,"description":15,"timeFrame":12},"Daily Stool Mass","Total mass of stool per day from measured BMs in grams",{"measure":17,"description":18,"timeFrame":12},"Duration of Diarrhea","Duration of diarrhea in hours from onset until 3 formed stools in a row",[20,23,26,29],{"measure":21,"description":22,"timeFrame":12},"Consumption of Study Intervention","Mls of ORT or FORT consumed per day",{"measure":24,"description":25,"timeFrame":12},"Stool Consistency","Stool consistency rated on the Bristol Stool Scale",{"measure":27,"description":28,"timeFrame":12},"Body Weight","Weight of child each day of study in kg",{"measure":30,"description":31,"timeFrame":12},"Stool Human Beta-Defensin-2 Content","Beta-defensin-2 measured from stool sample in ng\u002Fml",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":39},"TRIPLE",[40,41,42],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Amino acid-fortified oral rehydration therapy","EXPERIMENTAL","Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the World Health Organization (WHO) Treatment Plan A for ORT administration:\n\n* Child under 24 months: 50 to 100 ml ORT after each loose stool (approximately 500 ml daily)\n* Child from 2 to 10 years: 100 to 200 ml ORT after each loose stool (approximately 1000 ml daily)",[49],"Drug: Fortified Oral Rehydration Therapy",{"label":51,"type":52,"description":53,"interventionNames":54},"Standard of care oral rehydration therapy","PLACEBO_COMPARATOR","Participants will consume the standard of care oral rehydration therapy according to the WHO Treatment Plan A for ORT administration:\n\n* Child under 24 months: 50 to 100 ml after each loose stool (approximately 500 ml daily)\n* Child from 2 to 10 years: 100 to 200 ml after each loose stool (approximately 1000 ml daily)",[55],"Dietary Supplement: Standard of Care Oral Rehydration Therapy",[57,64],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DRUG","Fortified Oral Rehydration Therapy","Oral rehydration solution with reduced glucose and added amino acids.",[45],[63],"FORT",{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":32},"DIETARY_SUPPLEMENT","Standard of Care Oral Rehydration Therapy","Glucose-based oral rehydration therapy according to World Health Organization guidelines.",[51],[70],{"name":71,"affiliation":5,"role":72},"Paul Breslin, PhD","PRINCIPAL_INVESTIGATOR",[74,78],{"name":71,"role":75,"phone":76,"phoneExt":32,"email":77},"CONTACT","(848) 932-6085","breslin@monell.org",{"name":79,"role":75,"phone":80,"phoneExt":32,"email":81},"Payton Harmon","978-944-8484","payton.harmon@rutgers.edu",[83],{"facility":84,"status":85,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Robert Wood Johnson University Hospital","RECRUITING","New Brunswick","New Jersey","08901","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-74.45182,40.48622,{"lat":95,"lon":94},[98,102],{"name":99,"role":75,"phone":100,"phoneExt":32,"email":101},"Paul AS Breslin, PhD","848-932-6080","pasb@sebs.rutgers.edu",{"name":103,"role":75,"phone":80,"phoneExt":32,"email":81},"Payton Harmon, BS",{"type":105,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Paul A Breslin","Professor of Nutritional Sciences",[109],{"name":110,"class":6},"The Gerber Foundation","100526612","phase-1-fortified-oral-rehydration-therapy-for-pediatric-diarrhea-100526612",false,"NCT06137014","Fortified Oral Rehydration Therapy for Pediatric Diarrhea","Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy","fORT","Inclusion Criteria:\n\n* Between the ages of 6 months and 5 years.\n* Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.\n* Diarrhea presumed infectious\n\nExclusion Criteria:\n\n* Severe gastroenteritis with moderate to severe dehydration\n* Requiring inpatient care\n* Requiring antibiotics\n* Requiring IV rehydration\n* History of chronic diarrhea\n* Presenting with diarrhea for greater than 2 days prior to admission\n* Allergy to any of the ingredients in the study products\n* Inborn metabolic disorder of amino acids\n* Receives post-pyloric feedings","ALL","6 Months","5 Years",{"count":123,"type":124},72,"ESTIMATED","INTERVENTIONAL",[127,128],"PHASE1","PHASE2","The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are:\n\n* can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?\n* can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT?\n\nParticipants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.",[131],"Acute Gastroenteritis",[133,134,135,136],"Gastroenteritis","Intestinal Diseases","Pediatric Diseases","Diarrhea, Infantile","2026-02-09",{"date":139,"type":140},"2026-02-12","ACTUAL",{"date":142,"type":140},"2024-06-01",{"date":144,"type":124},"2027-06",{"name":106,"class":6},1]