[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655386":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":43,"studyPopulation":34,"armGroups":44,"interventions":57,"overallOfficials":67,"centralContacts":71,"locations":79,"responsibleParty":94,"collaborators":34,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":34,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":34,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":122,"whyStopped":34,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Can Tho University of Medicine and Pharmacy","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":34},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Duration of diarrhea","The cessation of acute diarrhea is determined when children met following criteria:\n\n1. Passing soft or formed stools twice in a row.\n2. No bowel movements recorded for 12 consecutive hours.\n3. Stool consistency returns to normal, corresponding to categories 3 to 5 on the Bristol stool scale.","Immediately after the intervention",{"measure":14,"description":15,"timeFrame":16},"The frequency of stool","Total number of bowel movements per day","At day 1, 3, 5",{"measure":18,"description":19,"timeFrame":16},"Stool consistency assessed by Bristol stool chart","The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool.",[21,24,27,30],{"measure":22,"description":23,"timeFrame":12},"Length of hospitalization","The total length of hospitalization, measured in days",{"measure":25,"description":26,"timeFrame":12},"Adverse events","The occurrence of adverse events during treatment, including such as rash and bloating.",{"measure":28,"description":29,"timeFrame":12},"Cost effectiveness","Total Cost per child from date of admission until discharge",{"measure":31,"description":32,"timeFrame":33},"Rate of Hospital readmission","The proportion of participants who were readmitted to the hospital after discharge","At day 14 and 28 after discharge from the hospital.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":34,"timePerspective":34,"maskingInfo":40},"RANDOMIZED","PARALLEL","The intervention group received Saccharomyces boulardii, while the control group received standard treatment.","TREATMENT",{"masking":41,"maskingDescription":42,"whoMasked":34},"NONE","The blinding method was not performed.","A total of 206 children diagnosed with acute diarrhea will be evaluated and divided into two groups based on a random distribution list: Group A and Group B.\n\nGroup A will be treated with standard methods including fluid replacement and zinc according to the Ministry of Health's protocol.\n\nGroup B will be treated similarly to Group A, but with the addition of Saccharomyces boulardii at a dose of 250 to 750 mg per day until discharge.\n\nBoth groups of children will receive the same counseling and monitoring, with guidance provided to parents.\n\nCaregivers are advised to record symptoms and stool diaries daily.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Saccharomyces boulardii","EXPERIMENTAL","Saccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays.",[50],"Drug: Saccharomyces Boulardii Probiotic Supplement",{"label":52,"type":53,"description":54,"interventionNames":55},"Standard treatment includes fluid replacement and zinc supplementation.","ACTIVE_COMPARATOR","Treatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge.",[56],"Drug: The child will be treated with standard method",[58,63],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":34},"DRUG","Saccharomyces Boulardii Probiotic Supplement","Children will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.",[46],{"type":59,"name":64,"description":65,"armGroupLabels":66,"otherNames":34},"The child will be treated with standard method","Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.",[52],[68],{"name":69,"affiliation":5,"role":70},"Thao Thi Phuong Nguyen, M.D","STUDY_CHAIR",[72,76],{"name":69,"role":73,"phone":74,"phoneExt":34,"email":75},"CONTACT","+84789212603","Whynottheo@gmail.com",{"name":77,"role":73,"phone":34,"phoneExt":34,"email":78},"Duc Long Tran, Ph.D","tdlong@ctump.edu.vn",[80],{"facility":5,"status":34,"city":81,"state":34,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Can Tho","900000","Vietnam","VN",{"type":86,"coordinates":87},"Point",[88,89],105.78825,10.03711,{"lat":89,"lon":88},[92],{"name":77,"role":73,"phone":93,"phoneExt":34,"email":78},"+842923739730",{"type":95,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Nguyễn Thị Phương Thão","Principal Investigator","100655386","efficacy-and-safety-of-saccharomyces-boulardii-in-treatment-of-acute-diarrhea-in-children-aged-6-months-to-5-years-old-100655386",false,"NCT07813182","Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old","Inclusion Criteria:\n\n* Age from 6 months to 5 years old\n* Children are diagnosed with acute diarrhea according to WHO criteria.\n\nExclusion Criteria:\n\n* Bloody, mucous stools.\n* Signs of sepsis requiring admission to the Intensive Care Unit.\n* Currently suffering from chronic diseases such as cow's milk protein allergy, nephrotic syndrome, immunodeficiency, and systemic diseases.\n* Currently using immunosuppressant drugs.",true,"ALL","6 Months","60 Months",{"count":109,"type":110},206,"ESTIMATED","INTERVENTIONAL",[113],"NA","This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods.",[116],"Acute Diarrhea",[118,119,120,121,83],"Acute diarrhea","Saccharomyces Boulardii","Children","Probiotics","NOT_YET_RECRUITING","2026-09-08",{"date":125,"type":126},"2026-09-10","ACTUAL",{"date":128,"type":110},"2026-08-31",{"date":130,"type":110},"2028-08-30",{"name":5,"class":6},1]