[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653202":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":35,"studyPopulation":26,"armGroups":36,"interventions":49,"overallOfficials":26,"centralContacts":60,"locations":66,"responsibleParty":81,"collaborators":26,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":26,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":109,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Child Health Sciences and Children's Hospital, Lahore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Antibiotic-Associated Diarrhea (AAD)","Proportion of participants who develop antibiotic-associated diarrhea, defined as 3 or more unformed\u002Floose stools per day or a single episode of watery stool starting at least 2 hours post-initiation of co-amoxiclav therapy.","From initiation of treatment through Day 14",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Stool Frequency","Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, \\>4 times per day).","Assessed at Day 1, Day 5, and Day 14.",{"measure":19,"description":20,"timeFrame":21},"Stool Consistency Grade","Stool consistency graded according to the WHO grading scale: Grade 1 (Normal formed), Grade 2 (Semi-formed), Grade 3 (Liquid stools taking shape of container), Grade 4 (Watery stools with flakes, opaque), Grade 5 (Watery stools with few flakes, translucent).","Assessed at Day 1, Day 5, and Day 14",{"measure":23,"description":24,"timeFrame":25},"Duration of Diarrhea","Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.","Up to Day 14 post-initiation of therapy",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":32,"maskingDescription":26,"whoMasked":33},"SINGLE",[34],"PARTICIPANT","Acute upper respiratory tract infections (URTI) frequently lead to broad-spectrum antibiotic prescriptions such as co-amoxiclav, which can disrupt the gut microbiota and cause antibiotic-associated diarrhea (AAD).\n\nThis single-blind randomized controlled trial will be conducted at the Pediatric Medicine Outpatient Department, University of Child Health Sciences, The Children's Hospital, Lahore. A total of 88 children aged 6 months to 5 years presenting with URTI and prescribed co-amoxiclav will be enrolled after obtaining written informed consent from their parents or legal guardians.\n\nParticipants will be randomized into two equal groups (n = 44 each):\n\nGroup A (Control): Standard dose of oral co-amoxiclav (30 mg\u002Fkg\u002Fday) for 5 days.\n\nGroup B (Intervention): Standard dose of oral co-amoxiclav (30 mg\u002Fkg\u002Fday) plus oral Saccharomyces boulardii for 5 days.\n\nClinical response, stool frequency, and stool consistency (graded using the WHO scale) will be assessed telephonically and during clinical follow-up at Day 5 (completion of antibiotic regimen) and at Day 14. Any child developing severe dehydration or high-grade loose stools will be managed in accordance with institutional safety protocols.",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Group A: Control Group","ACTIVE_COMPARATOR","Participants receive standard oral co-amoxiclav (30 mg\u002Fkg\u002Fday) for 5 days.",[42],"Drug: Co-amoxiclav",{"label":44,"type":45,"description":46,"interventionNames":47},"Group B:Intervention Group","EXPERIMENTAL","Participants receive standard oral co-amoxiclav (30 mg\u002Fkg\u002Fday) plus oral Saccharomyces boulardii for 5 days.",[42,48],"Dietary Supplement: Saccharomyces boulardii",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"DRUG","Co-amoxiclav","30 mg\u002Fkg\u002Fday orally for 5 days.",[38,44],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":26},"DIETARY_SUPPLEMENT","Saccharomyces boulardii","Administered orally alongside standard co-amoxiclav for 5 days.",[44],[61],{"name":62,"role":63,"phone":64,"phoneExt":26,"email":65},"Gul Jabeen, MBBS","CONTACT","+923330937322","aabigul96@gmail.com",[67],{"facility":68,"status":26,"city":69,"state":70,"zip":26,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"University of Child Health sciences, Children's hospital,Lahore","Lahore","Punjab Province","Pakistan","PK",{"type":74,"coordinates":75},"Point",[76,77],74.35071,31.558,{"lat":77,"lon":76},[80],{"name":62,"role":63,"phone":64,"phoneExt":26,"email":65},{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Gul Jabeen","MD paediatrics post graduate resident","100653202","effectiveness-of-saccharomyces-boulardii-in-prevention-of-antibiotic-associated-diarrhea-100653202",false,"NCT07785206","Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea","Effectiveness of Saccharomyces Boulardii in the Prevention of Antibiotic-Associated Diarrhea Among Children Receiving Co-amoxiclav for Upper Respiratory Tract Infection: A Randomized Control Trial","Inclusion Criteria:\n\n* Children aged 6 months to 5 years presenting with upper respiratory tract infection (URTI)\n* Prescribed standard oral co-amoxiclav therapy\n* Both male and female patients\n* Written informed consent provided by parents or legal guardians\n\nExclusion Criteria:\n\n* Presence of diarrhea at the time of study enrollment\n* Prior use of probiotics during the current course of illness\n* Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment\n* Concomitant use of other medications\n* Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii\n* Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy\n* History of chronic diarrhea\n* Presence of 3rd degree (severe) malnutrition\n* Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)","ALL","6 Months","5 Years",{"count":96,"type":97},88,"ESTIMATED","INTERVENTIONAL",[100],"NA","Antibiotic-associated diarrhea (AAD) is a common adverse effect in pediatric patients receiving broad-spectrum antibiotics such as co-amoxiclav for upper respiratory tract infections (URTI). This study aims to evaluate the effectiveness of the probiotic Saccharomyces boulardii in preventing antibiotic-associated diarrhea among children aged 6 months to 5 years receiving co-amoxiclav. Participants will be randomly allocated to receive either standard co-amoxiclav therapy alone or co-amoxiclav combined with Saccharomyces boulardii for 5 days. The primary objective is to evaluate whether the addition of Saccharomyces boulardii reduces the incidence of diarrhea during and up to 14 days following antibiotic therapy.",[103,104],"Antibiotic Associated Diarrhea","Upper Respiratory Tract Infection",[57,106,52,107,108],"Probiotics","Pediatrics","Diarrhea Prevention","NOT_YET_RECRUITING","2026-08-20",{"date":112,"type":113},"2026-08-25","ACTUAL",{"date":115,"type":97},"2026-09",{"date":117,"type":97},"2027-05",{"name":5,"class":6},1]