[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610966":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":25,"responsibleParty":40,"collaborators":43,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":25,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":25,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":25,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brevicillin® gocce (Bifidobacterium breve PRL2020)","EXPERIMENTAL","Participants will receive Brevicillin® gocce, a probiotic food supplement containing Bifidobacterium breve PRL2020 (LMG S-32458), alongside standard antibiotic therapy with amoxicillin or amoxicillin\u002Fclavulanic acid.\n\nDosage and administration: 5 drops, 2-3 times per day (depending on antibiotic dosing schedule), administered during the antibiotic treatment period (6-10 days). After completion of antibiotic therapy, participants will enter a follow-up period until day 15 without probiotic administration.",[13],"Dietary Supplement: Brevicillin® gocce (Bifidobacterium breve PRL2020)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive a placebo formulation matched in appearance, packaging, and dosing schedule to Brevicillin® gocce, administered alongside standard antibiotic therapy with amoxicillin or amoxicillin\u002Fclavulanic acid.\n\nThe placebo will be given at the same frequency (5 drops, 2-3 times per day) and duration as the experimental product during the antibiotic treatment period (6-10 days). After antibiotic completion, participants will enter a follow-up period until day 15 without placebo administration.",[19],"Other: Placebo (matching oil drops)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Brevicillin® gocce is a probiotic dietary supplement in oily drops containing the bacterial strain Bifidobacterium breve PRL2020 (LMG S-32458). Each 5-drop dose contains approximately 5 billion live cells. The supplement is administered orally 2-3 times per day, in parallel with antibiotic therapy (amoxicillin or amoxicillin\u002Fclavulanic acid), for 6-10 days only (during the antibiotic course).\n\nAfter completion of antibiotic therapy, participants enter a follow-up period until day 15 without probiotic administration. The product is manufactured by PharmExtracta S.p.A., Pontenure, Italy.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo (matching oil drops)","The placebo is a formulation identical in appearance, packaging, and administration schedule to Brevicillin® gocce but without the Bifidobacterium breve PRL2020 strain. It is administered orally 2-3 times per day only during the antibiotic treatment period (6-10 days).\n\nAfter antibiotic completion, participants enter a follow-up period until day 15 without placebo administration.",[15],[31],{"name":32,"affiliation":33,"role":34},"Davide Sisti, PhD","University of Urbino \"Carlo Bo\"","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+39-0722-303301","davide.sisti@uniurb.it",{"type":34,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine",[44],{"name":33,"class":6},"100610966","evaluation-of-the-use-of-a-probiotic-containing-bifidobacterium-breve-prl2020-in-oral-drops-in-preventing-side-effects-from-amoxicillin-or-amoxicillinclavulanic-acid-antibiotic-use-100610966",false,"NCT07234448","Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid Antibiotic Use","Evaluation of the Use of a Probiotic Containing Bifidobacterium Breve PRL2020 in Oral Drops in Preventing Side Effects From Amoxicillin or Amoxicillin\u002FClavulanic Acid Antibiotic Use: a Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Male and female participants aged 0-12 years.\n* Undergoing antibiotic therapy with amoxicillin or amoxicillin\u002Fclavulanic acid.\n* Parent or legal guardian provides written informed consent.\n\nExclusion Criteria:\n\n* Use of antibiotic therapy within 4 weeks prior to enrolment.\n* Use of other probiotic products or lactic acid bacteria during the study.\n* Pre-existing diarrhea within 4 weeks prior to enrolment.\n* Chronic inflammatory bowel disease.\n* Immunodeficiency.\n* Lack of parental or legal guardian consent to participate in the study.","ALL","0 Years","12 Years",{"count":56,"type":57},1000,"ESTIMATED","INTERVENTIONAL",[60],"NA","This multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of the probiotic Bifidobacterium breve PRL2020 (Brevicillin® gocce) in preventing gastrointestinal side effects associated with antibiotic therapy using amoxicillin or amoxicillin\u002Fclavulanic acid in pediatric patients aged 0-12 years. Participants will be randomized 1:1 to receive either the probiotic supplement or placebo during standard antibiotic treatment for 6-10 days, followed by a post-treatment observation period up to day 15 without probiotic or placebo administration. The primary objective is to assess the reduction in the incidence of antibiotic-associated diarrhea (AAD).",[63],"Antibiotic-associated Diarrhea","NOT_YET_RECRUITING","2025-11-19",{"date":67,"type":68},"2025-11-24","ACTUAL",{"date":70,"type":57},"2025-12-01",{"date":72,"type":57},"2026-05-29",{"name":5,"class":6}]