[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659970":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":11,"studyPopulation":11,"armGroups":53,"interventions":66,"overallOfficials":11,"centralContacts":75,"locations":81,"responsibleParty":99,"collaborators":11,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":11,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":11,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":11,"overallStatus":122,"whyStopped":11,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Szent Miklós Szolgálat Kft.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent of observation periods with absence of symptoms in children 4 years to 17 years old with symptoms of viral upper-respiratory tract infection",null,"14 days",[14,18,21,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Duration of symptoms","Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough) measured from baseline and to end of intervention (14 completed days of intervention).","14 completed days of intervention",{"measure":19,"description":20,"timeFrame":17},"Severity of symptoms","Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough), recorded in a \"Symptom Diary\" based on the clinically validated \"Wisconsin Upper Respiratory Symptom Survey 11\" (WURSS-11), but modified according to the study's characteristics.",{"measure":22,"description":23,"timeFrame":17},"Duration of fever","Duration of fever, defined as the total number of hours that the child has a core temperature \\>38oC measured twice per day measured from baseline and to end of intervention (14 completed days of intervention).",{"measure":25,"description":26,"timeFrame":17},"Amount of anti-pyretic and analgesic medication","Amount of anti-pyretic and analgesic medication, such as NSAIDs used from baseline and to end of intervention (14 completed days of intervention)",{"measure":28,"description":29,"timeFrame":17},"Number of children receiving antibiotic treatment","Number of children receiving antibiotic treatment in each treatment group measured from baseline and to end of intervention (14 completed days of intervention).",{"measure":31,"description":32,"timeFrame":17},"Total amount of days of antibiotic use","Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the \"Symptom Diary\" measured from baseline and to end of intervention (14 completed days of intervention).",{"measure":34,"description":35,"timeFrame":17},"Number of unplanned medical visits","Number of unplanned medical visits (other than \"Visit 1 and 2\"). This outcome is defined as the total amount of medical office visits or emergency visits related to the infection, measured from baseline and to end of intervention (14 completed days of intervention)",{"measure":37,"description":38,"timeFrame":17},"Days of absences from day care center\u002Fschool.","This outcome is defined as the total amount of days of absences from the day care centre during the study, due to the presence of episodes of URTI, measured from baseline and to end of intervention (14 completed days of intervention).",{"measure":40,"description":41,"timeFrame":17},"Safety of study product","This outcome includes registration of all adverse events, serious adverse events and monitoring of vital signs.",{"allocation":43,"interventionModel":44,"interventionModelDescription":11,"primaryPurpose":45,"observationalModel":11,"timePerspective":11,"maskingInfo":46},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":47,"maskingDescription":11,"whoMasked":48},"QUADRUPLE",[49,50,51,52],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Probiotics","ACTIVE_COMPARATOR","Study product containing L. reuteri (DSM 17938 and DSM 33633) taken orally once in the morning and once in the evening, each time 5 drops.",[59],"Dietary Supplement: Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)",{"label":61,"type":62,"description":63,"interventionNames":64},"Placebo","PLACEBO_COMPARATOR","Placebo taken orally once in the morning and once in the evening, each time 5 drops.",[65],"Other: Placebo",[67,72],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":11},"DIETARY_SUPPLEMENT","Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)","Probiotics drops (L. reuteri DSM 17938 and L. reuteri DSM 33633) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.",[55],{"type":6,"name":61,"description":73,"armGroupLabels":74,"otherNames":11},"Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.",[61],[76],{"name":77,"role":78,"phone":79,"phoneExt":11,"email":80},"Gergely Milosevits","CONTACT","+36308425722","drgergelymilosevits@gmail.com",[82],{"facility":5,"status":11,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Szigetszentmiklós","Pest County","2310","Hungary","HU",{"type":89,"coordinates":90},"Point",[91,92],19.04335,47.34382,{"lat":92,"lon":91},[95,97],{"name":96,"role":78,"phone":79,"phoneExt":11,"email":80},"Gergely Milosevits, M.D., PhD.",{"name":96,"role":98,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Milosevits Gergely","Principal Investigator","100659970","a-study-to-investigate-the-effect-of-probiotics-l-reuteri-dsm-17938-and-l-reuteri-dsm-33633-on-symptoms-of-viral-upper-respiratory-tract-infections-in-children-100659970",false,"NCT07870824","A Study to Investigate the Effect of Probiotics (L. Reuteri DSM 17938 and L. Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children","A Randomized, Double Blind, Placebo-controlled Study to Investigate the Effect of Probiotics (L. Reuteri DSM 17938 and L. Reuteri DSM 33633) on Symptoms of Viral Upper Respiratory Tract Infections in Children","Inclusion Criteria:\n\n* Children with symptoms of upper respiratory tract infection (coughing\u002Ffever\u002Fsneezing\u002Frunny or congested nose\u002Fpharynx pain)\n* Any gender\n* Age from 4 years to 17 years\n* Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years\n* Negative Strep test\n\nExclusion Criteria:\n\n* Use of antibiotics or probiotics in the 10 days prior to study enrolment\n* Use of a probiotic other than the test sample during the study\n* Eight or more otitis media within 12 months\n* Two or more bacterial sinusitis within 12 months\n* Two or more pneumonia episodes within 12 months\n* History of two or more invasive infections (meningitis, cellulitis, osteomyelitis, septicaemia)\n* Chronic diarrhea\n* Recurrent deep skin or organ abscesses\n* Persistent superficial candidiasis\n* Use of antibiotics for two months or more to treat respiratory infections within 12 months\n* Gastroesophageal reflux\n* Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy\n* Primary or secondary ciliary dyskinesia\n* Congenital malformations of the respiratory tract","ALL","4 Years","17 Years",{"count":114,"type":115},194,"ESTIMATED","INTERVENTIONAL",[118],"NA","This study investigates the effect of Lactobacillus reuteri probiotic strains (DSM 17938 and L. reuteri DSM 33633) on symptoms of viral upper-respiratory tract infections in children.",[121],"Virus Diseases in Children","NOT_YET_RECRUITING","2026-10-06",{"date":125,"type":126},"2026-10-13","ACTUAL",{"date":128,"type":115},"2026-10-12",{"date":130,"type":115},"2028-03-30",{"name":101,"class":6},1]