[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581469":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":33,"locations":34,"responsibleParty":51,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":33,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":33,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":33,"overallStatus":77,"whyStopped":33,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic + Antibiotic Group (Probiotic Group)","EXPERIMENTAL","Participants in this group will receive Amoxicillin or Amoxicillin\u002FClavulanic Acid as prescribed by their physician, and a probiotic as add-on for the duration of antibiotic therapy (6-10 days).",[13,14],"Dietary Supplement: Bifidobacterium breve PRL2020 (Brevicillin®)","Drug: Amoxicillin or Amoxicillin\u002FClavulanic Acid",{"label":16,"type":17,"description":18,"interventionNames":19},"Antibiotic-Only Group (Control Group)","ACTIVE_COMPARATOR","Participants in this group will receive only Amoxicillin or Amoxicillin\u002FClavulanic Acid as per medical prescription.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bifidobacterium breve PRL2020 (Brevicillin®)","Probiotic Bifidobacterium breve PRL2020 (Brevicillin®) at a dose of 20 billion CFU per day (one stick in the morning and one in the evening).",[9],[27],"Brevicillin®, PharmExtracta S.p.A.",{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Amoxicillin or Amoxicillin\u002FClavulanic Acid","Treatment of Amoxicillin or Amoxicillin\u002FClavulanic Acid as per medical prescription.",[16,9],null,[35],{"facility":36,"status":33,"city":37,"state":33,"zip":33,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Medicine & Technological Innovation Dept. University of Insubria","Varese","Italy","IT",{"type":41,"coordinates":42},"Point",[43,44],8.82511,45.82058,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":33,"phoneExt":33,"email":50},"Dr. Francesco Di Pierro, PhD","CONTACT","f.dipierro@vellejaresearch.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental medicine",[56],{"name":57,"class":6},"Università degli Studi dell'Insubria","100581469","evaluation-of-bifidobacterium-breve-prl2020-in-preventing-antibiotic-associated-side-effects-from-amoxicillin-or-amoxicillinclavulanic-acid-100581469",false,"NCT06850714","Evaluation of Bifidobacterium Breve PRL2020 in Preventing Antibiotic-Associated Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid","Evaluation of the Use of Bifidobacterium Breve PRL2020 in Preventing Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid Antibiotic Use: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 3 to 12 years\n* Requiring antibiotic therapy with Amoxicillin or Amoxicillin\u002FClavulanic Acid\n* Ability to comply with the study protocol (parents\u002Fcaregivers must complete symptom diaries)\n\nExclusion Criteria:\n\n* Use of any antibiotic therapy within 3 months before study enrollment\n* Known gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease)\n* History of chronic diarrhea or constipation\n* Allergy to probiotics or study interventions\n* Any immunocompromised state","ALL","3 Years","12 Years",{"count":69,"type":70},800,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study aims to evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 in preventing gastrointestinal and extra-intestinal side effects caused by Amoxicillin or Amoxicillin\u002FClavulanic Acid in pediatric patients. The study will compare a treatment group receiving the probiotic alongside antibiotics with a control group receiving antibiotics alone. The primary focus is on reducing antibiotic-induced intestinal discomfort through microbiota modulation.",[76],"Antibiotic Side Effect","NOT_YET_RECRUITING","2025-02-27",{"date":80,"type":81},"2025-03-04","ACTUAL",{"date":83,"type":70},"2025-02-23",{"date":85,"type":70},"2025-12-31",{"name":5,"class":6},1]