[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583933":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":44,"centralContacts":48,"locations":55,"responsibleParty":73,"collaborators":53,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":53,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":102,"whyStopped":53,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Nebraska","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"2 mL SunButyrate-TG (Arm1)","EXPERIMENTAL","Participants will receive 2 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.",[13],"Drug: 2 mL SunButyrate-TG",{"label":15,"type":10,"description":16,"interventionNames":17},"4 mL SunButyrate-TG (Arm 2)","Participants will receive 4 milliliter (mL) SunButyrate-TG once daily for 3 weeks prior to cardiac surgery.",[18],"Drug: 4 mL SunButyrate-TG",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Comparator (Arm 3)","PLACEBO_COMPARATOR","Participants will receive either 2 milliliter (mL) or 4 mL of an inactive oil-based placebo once daily for 3 weeks prior to cardiac surgery.",[24],"Drug: Placebo",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","2 mL SunButyrate-TG","Participants randomized into the 2 milliliter (mL) SunButyrate-TG will take the supplement once daily for 3 weeks prior to cardiac surgery.\n\nNote: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.",[9],[32],"Butyrate Liquid Supplement",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Placebo","Participants randomized into the Placebo arm will take the oil-based placebo once daily for 3 weeks prior to cardiac surgery",[20],[38],"sugar pill",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"4 mL SunButyrate-TG","Participants randomized into the 4 mL SunButyrate-TG arm will take the supplement once daily for 3 weeks prior to cardiac surgery.\n\nNote: This is a Dietary Supplement, but the FDA requires an Investigational New Drug (IND) number because inflammation is being treated.",[15],[32],[45],{"name":46,"affiliation":5,"role":47},"Jeffrey Salomon, MD, MBA","PRINCIPAL_INVESTIGATOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Jeffrey D Salomon, MD, MBA","CONTACT","940-453-7166",null,"jeffrey.salomon@unmc.edu",[56],{"facility":57,"status":53,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Children's Nebraska, 8200 Dodge St","Omaha","Nebraska","68114","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-95.94043,41.25626,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":53,"email":54},"Jeffrey D Salomon, MD","402-955-4264",{"type":74,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100583933","phase-1-butyric-acid-supplementation-for-gut-improvement-after-cardiac-surgery-in-kids-100583933",false,"NCT06882772","Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids","Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids, A Phase IIa Clinical Trial","BASICS-Kids","Inclusion Criteria:\n\n* Infants and Children undergoing cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Antibiotics, surgery, or chemotherapy within the past 8 weeks\n* Continuous enteral feeds before surgery\n* GI pathology or intestinal surgery (excluding G-tube)\n* Liver disease with elevated transaminitis or dialysis-dependent renal disease","ALL","1 Month","3 Years",{"count":87,"type":88},105,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE1","PHASE2","Butyric acid has been shown to promote gut health and improve the microbiome in multiple adult studies. In preliminary studies in older children with inflammatory bowel disease, butyric acid was shown to be safe. However, it's suitability for infants and young children with congenital heart disease (CHD) has yet to be determined.\n\nThis study will examine butyric acid supplementation in infants and children, ages 1 month to 3 years, with CHD who require cardiac surgery with cardiopulmonary bypass. Study goals include determining the safety and tolerability of butyric acid supplementation before cardiac surgery, and to identify changes in gut microbial communities, metabolic profile, and genetic markers intestinal function. Also, the study seeks to establish a reduction in inflammation (inflammatory signaling) after cardiopulmonary bypass (CPB) in participants receiving butyric acid.",[95],"Congenital Heart Disease (CHD)",[97,98,99,100,101],"Congenital Heart Disease","Gut Health","Microbiome","Gut Barrier Function","Inflammation","NOT_YET_RECRUITING","2026-02-21",{"date":105,"type":106},"2026-02-24","ACTUAL",{"date":108,"type":88},"2026-03",{"date":110,"type":88},"2029-12",{"name":5,"class":6},1]