[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611072":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bactoblis® Evol","EXPERIMENTAL","Participants randomized to Sequence A will receive Streptococcus salivarius Evol12® (Bactoblis® Evol) for 3 months, followed by a 7-day wash-out, then matching placebo for 3 months. Bactoblis® Evol is taken as 1 orodispersible tablet nightly, allowed to dissolve slowly in the mouth.",[13],"Dietary Supplement: Bactoblis® Evol (Streptococcus salivarius Evol12®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to Sequence B will receive matching placebo for 3 months, followed by a 7-day wash-out, then Streptococcus salivarius Evol12® (Bactoblis® Evol) for 3 months. The placebo tablets are identical in appearance, taste, and packaging to the active product.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bactoblis® Evol (Streptococcus salivarius Evol12®)","Bactoblis® Evol is an orodispersible tablet containing the probiotic strain Streptococcus salivarius Evol12® (LMG P-33696), used to support the balance of the oral microbiota. Each tablet is taken once daily in the evening, allowing it to dissolve slowly in the mouth without chewing, eating, or drinking afterward. Treatment is administered for 3 consecutive months during each treatment period. The product is manufactured by PharmExtracta S.p.A., Pontenure, Italy.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Matching placebo orodispersible tablet identical in appearance, flavor, and packaging to Bactoblis® Evol but without the active probiotic strain. Administered once daily in the evening for 3 months during the assigned treatment period.",[15],[31],"Placebo (matching orodispersible tablet)",[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Davide Sisti, PhD","CONTACT","+39-0722-303301","davide.sisti@uniurb.it",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Università di Urbino Carlo Bo","RECRUITING","Urbino","PU (Pesaro E Urbino)","61029","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],12.63633,43.72621,{"lat":51,"lon":50},[54],{"name":34,"role":35,"phone":26,"phoneExt":26,"email":37},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Dr. Amjad Khan","Professor of Clinical Biochemistry and Experimental Medicine",[60],{"name":61,"class":6},"University of Urbino \"Carlo Bo\"","100611072","evaluation-of-the-efficacy-of-streptococcus-salivarius-evol12-in-the-reduction-of-recurrent-adenotonsillitis-in-children-100611072",false,"NCT07235826","Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children","Evaluation of the Efficacy of Streptococcus Salivarius Evol12® in the Reduction of Recurrent Adenotonsillitis in Children: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Cross-over Clinical Trial","Inclusion Criteria:\n\n* Male and female children aged 3 to 11 years.\n* History of ≥3 documented episodes of acute adenotonsillitis within the previous 12 months, each characterized by fever ≥38°C.\n* Signed and accepted informed consent from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Total obstruction of the nasal cavities.\n* Uncontrolled gastroesophageal reflux disease.\n* Unilateral tonsillar enlargement.\n* Previous tonsil reduction surgery.\n* Lack of parental or legal guardian consent to participate in the study.","ALL","3 Years","11 Years",{"count":73,"type":74},200,"ESTIMATED","INTERVENTIONAL",[77],"NA","This prospective, multicenter, randomized, double-blind, placebo-controlled, cross-over clinical trial will evaluate the efficacy and safety of Streptococcus salivarius Evol12® (Bactoblis® Evol) in reducing the recurrence and duration of acute febrile adenotonsillitis in children aged 3 to 11 years. Participants will receive either the probiotic or a matching placebo for 3 months, followed by a 7-day wash-out and a second 3-month treatment period with the alternative product. The study will assess changes in the incidence and duration of adenotonsillar episodes, antibiotic use, school absences, and sleep quality.",[80],"Recurrent Tonsillitis","2025-11-17",{"date":83,"type":84},"2025-11-19","ACTUAL",{"date":86,"type":84},"2025-09-01",{"date":88,"type":74},"2026-06-30",{"name":5,"class":6},1]