[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637512":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":103,"collaborators":30,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":114,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":30,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":132,"whyStopped":30,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Lallemand Pharma AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PMBL® sublingual tablet","ACTIVE_COMPARATOR","Ismigen® (Polyvalent Mechanical Bacterial Lysate; PMBL) is a sublingual tablet marketed by Lallemand Pharma Europe. Each tablet contains:\n\n* Lyophilised bacterial lysate 50 mg\n* Excipients q.s. 250mg\n\nThe posology of Ismigen® for paediatric population (from 3 years of age) is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months.",[13],"Drug: Bacterial Lysates",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","The comparator is a sublingual tablet, indistinguishable from the investigational product.\n\nEach tablet of placebo comparator has the same composition as the investigational medicinal product being tested (with the exception of the active substance, which is replaced by glycine (7 mg)). Posology, instructions for use, contraindications, precautions of use and labelling are identical to those for Ismigen®.\n\nThe posology of Placebo is one tablet per day before food, to be dissolved under the tongue. Use for ten consecutive days per month, over a period of 3 months.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bacterial Lysates","3-month period, 10 days per months during the fall-winter",[9],[9,27],"ISMIGEN®",{"type":22,"name":15,"description":24,"armGroupLabels":29,"otherNames":30},[15],null,[32],{"name":33,"affiliation":34,"role":35},"Andrzej EMERYK, MD, PhD","University Children Hospital, Lublin, Poland","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Bernard GOUT, PharmD, PhD","CONTACT","+33776583905","bgout@pharmndev.ch",[43,54,61,68,75,82,89,96],{"facility":44,"status":30,"city":45,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":30},"Research Site","Bialystok","Poland","PL",{"type":49,"coordinates":50},"Point",[51,52],23.16433,53.13333,{"lat":52,"lon":51},{"facility":44,"status":30,"city":55,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":56,"geoPoint":60,"contacts":30},"Bydgoszcz",{"type":49,"coordinates":57},[58,59],18.00762,53.1235,{"lat":59,"lon":58},{"facility":44,"status":30,"city":62,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":30},"Krakow",{"type":49,"coordinates":64},[65,66],19.93658,50.06143,{"lat":66,"lon":65},{"facility":44,"status":30,"city":69,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":70,"geoPoint":74,"contacts":30},"Krąków",{"type":49,"coordinates":71},[72,73],18.51595,51.72921,{"lat":73,"lon":72},{"facility":44,"status":30,"city":76,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":30},"Lublin",{"type":49,"coordinates":78},[79,80],22.57009,51.25058,{"lat":80,"lon":79},{"facility":44,"status":30,"city":83,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":84,"geoPoint":88,"contacts":30},"Oświęcim",{"type":49,"coordinates":85},[86,87],19.21037,50.03437,{"lat":87,"lon":86},{"facility":44,"status":30,"city":90,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":95,"contacts":30},"Poznan",{"type":49,"coordinates":92},[93,94],16.92993,52.40692,{"lat":94,"lon":93},{"facility":44,"status":30,"city":97,"state":30,"zip":30,"country":46,"countryCode":47,"cosmosGeoPoint":98,"geoPoint":102,"contacts":30},"Tarnów",{"type":49,"coordinates":99},[100,101],20.98698,50.01381,{"lat":101,"lon":100},{"type":104,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100637512","phase-4-prevention-with-ismigen-of-rtis-in-kids-100637512",false,"NCT07578012","Prevention With Ismigen of RTIs in Kids","A Randomized Double-blind Placebo-controlled Study to Demonstrate the Efficacy of PMBL® Sublingual Tablets in Reducing the Incidence of Respiratory Tract Infections in Children Aged 3-12 Years (PIRTIK).","PIRTIK","Inclusion Criteria:\n\n1. Children of both genders aged from 3 to 12 years.\n2. Written informed consent obtained from the parents\u002Flegally authorized representatives\n3. Written assent obtained from the subject from 7 years\n4. Subject presenting with a susceptibility to respiratory tract infections according to the investigator\n5. No respiratory tract infection within 15 days before the randomization visit\n6. All girls of childbearing potential have a negative pregnancy urine testing at randomization visit and are informed and their parents as well of the requirement for contraception during the study.\n7. A cooperative attitude and ability to correct use of PMBL® tablet.\n\nExclusion Criteria:\n\n1. Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment.\n2. Body temperature ≥ 37.5°C at the randomization visit.\n3. Pregnant\u002FLactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.\n4. Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis.\n5. Known sensitivity to the components of study medication.\n6. Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study.\n7. Treatment with the following medications:\n\n   1. Injection or oral administration of steroids within 4 weeks prior to study enrolment.\n   2. Previous and\u002For concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment.\n8. Inability to understand or comply with study procedures or with study treatment intake.\n9. Subject participating in another interventional clinical study at the time of screening visit.",true,"ALL","3 Years","12 Years",{"count":118,"type":119},224,"ESTIMATED","INTERVENTIONAL",[122],"PHASE4","Although the efficacy of PMBL® sublingual tablets is evident to most prescribers, the clinical studies available to demonstrate the efficacy of this bacterial lysate in preventing recurrent respiratory tract infections have undeniable methodological biases. To demonstrate the efficacy of PMBL® in the pediatric population without questionable bias, a randomized double-blind Placebo-controlled study will be conducted: one arm of children presenting with a risk of recurrent respiratory tract infections will be treated with PMBL® for a 3-month period, 10 days per months during the fall-winter whereas subjects of the Placebo arm will receive sublingual tablet indistinguishable from PMBL® but without active ingredients. Both groups of subjects will be followed for four additional months. To improve the accuracy of data and the tracking of respiratory tract infections (RTI), a diary will be provided to each subject, allowing them to report the event as soon as it occurs. If necessary, a visit may be planned to enable the investigator to assess the event accurately.",[125,126],"Respiratory Tract Infections (RTI)","Healthy Children",[125,23,128,129,130,131],"PMBL® sublingual tablets","Recurrent Respiratory Tract Infections","Ismigen","Incidence","NOT_YET_RECRUITING","2026-05-05",{"date":135,"type":136},"2026-05-11","ACTUAL",{"date":138,"type":119},"2026-05",{"date":140,"type":119},"2027-04",{"name":5,"class":6},8]