[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550625":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":35,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":43,"collaborators":11,"id":47,"slug":11,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.",null,"up to 4 weeks",[14],{"measure":15,"description":11,"timeFrame":16},"The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)","up to 4weeks",{"allocation":18,"interventionModel":19,"interventionModelDescription":11,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE","Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.\n\nPhototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.\n\nProbiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.",[25,29],{"label":26,"type":27,"description":28,"interventionNames":11},"control","NO_INTERVENTION","no intervention",{"label":30,"type":31,"description":32,"interventionNames":33},"probiotics","ACTIVE_COMPARATOR","will receive 5 drops of probiotic supplement containing Bacillus clausil spores (Enterogermania amp 2 billion\u002F5 mL) once daily plus phototherapy till discharge.",[34],"Drug: Probiotic Formula",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Probiotic Formula","drops of probiotic supplement containing bacillus clausil spores (Enterogermania Amp 2 Billion\u002F5Ml )",[30],[42],"lactobacillus",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Samah Safwat","Principal investigator","100550625",false,"NCT06449508","The Effectiveness of Probiotics in Neonatal Jaundice","Role of Probiotics Administered as an Adjuvant Therapy in Pathological Neonatal Unconjugated Hyperbilirubinemia","Inclusion Criteria:\n\n* Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg\u002Fdl and need phototherapy.\n\nExclusion Criteria:\n\n* neonates who have kernicterus.\n* neonates who have ventilation problem.\n* neonates who have heart failure.\n* -neonates who have asphyxia.\n* neonates who have history of Rh incompatibility","ALL","1 Day","30 Days",{"count":57,"type":58},44,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.",[65],"Jaundice, Neonatal","NOT_YET_RECRUITING","2024-06-07",{"date":69,"type":70},"2024-06-10","ACTUAL",{"date":72,"type":58},"2024-07-01",{"date":74,"type":58},"2025-07-01",{"name":5,"class":6}]