[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623675":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":38,"centralContacts":47,"locations":56,"responsibleParty":71,"collaborators":30,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":30,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":104,"whyStopped":30,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Anabio R&D","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","The placebo group receives 0.9% NaCl physiological saline. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time (totally 6 sprays each time) for 8 weeks.\n\nThe placebo group also receives oral Reverse Osmosis water twice daily, 5 mL per dose, for 8 weeks The Placebo group receives standard pneumonia treatment: oxygen (SpO2 \\\u003C 92%) and antibiotics (ampicillin\u002Fsulbactam, with or without aminoglycosides\u002Fthird-generation cephalosporins). Vancomycin\u002Fmacrolides cover staphylococcal\u002Fatypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids\u002Felectrolytes, nutrition, physiotherapy. Bronchodilators\u002Fcorticosteroids are used for bronchospasm or severe pneumonia.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Navax","EXPERIMENTAL","The Navax group receives LiveSpo® Navax product, which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU\u002FmL x 30 mL. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 in the throat, for 8 weeks.\n\nThe Navax group also receives oral RO water twice daily, 5 mL per dose, for 8 weeks.\n\nThe Navax group receives standard pneumonia treatment: oxygen (SpO2 \\\u003C 92%) and antibiotics (ampicillin\u002Fsulbactam, with or without aminoglycosides\u002Fthird-generation cephalosporins). Vancomycin\u002Fmacrolides cover staphylococcal\u002Fatypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids\u002Felectrolytes, nutrition, physiotherapy. Bronchodilators\u002Fcorticosteroids are used for bronchospasm or severe pneumonia.",[19],"Combination Product: Navax",{"label":21,"type":16,"description":22,"interventionNames":23},"Navax-PregMom","The Navax-PregMom group receives LiveSpo® Navax product which is NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU\u002FmL x 30 mL. Caregivers will spray the children three times daily, administering 3 sprays in each nostril and 3 sprays in the throat each time for 8 weeks.\n\nThe Navax-PregMom group is also given oral medication with LiveSpo® Preg-Mom which is RO water plus B. subtilis, B. clausii, and B. coagulans at 3 billion CFU\u002F5mL. The children will receive the probiotic twice daily, with 1 vial per dosefor 8 weeks.\n\nThe Navax-PregMom group receives standard pneumonia treatment: oxygen (SpO2 \\\u003C 92%) and antibiotics (ampicillin\u002Fsulbactam, with or without aminoglycosides\u002Fthird-generation cephalosporins). Vancomycin\u002Fmacrolides cover staphylococcal\u002Fatypical agents; levofloxacin is an alternate. Adjust per antibiogram. Supportive care: antipyretics, suctioning, fluids\u002Felectrolytes, nutrition, physiotherapy. Bronchodilators\u002Fcorticosteroids are used for bronchospasm or severe pneumonia.",[24],"Combination Product: Navax-PregMom",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"OTHER","0.9% NaCl physiological saline is prepared by extracting 5 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B. Braun, Germany, product declaration No. Nasal-spraying 0.9% NaCl physiological saline is prepared by extracting 30 mL from 0.9% NaCl intravenous infusion 500 mL PP bottle (B.Braun, Germany, product declaration No. VD-32732-19), and then pouring it into the same opaque plastic spraying 20 mL-bottle that is used for nasal-oropharyngeal probiotic spray.\n\nReverse Osmosis water (Aquafina, PepsiCo) is produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM but contain 5 mL of high-quality RO water from Aquafina.",[9],null,{"type":32,"name":15,"description":33,"armGroupLabels":34,"otherNames":30},"COMBINATION_PRODUCT","In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device (Product declaration: No. 210001337\u002FPCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax product is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU\u002FmL x 20 mL.\n\nRO water (Aquafina, PepsiCo) produced under ISO 9001:2015 and ISO 22000:2018 standards. The RO water ampoules are produced using a similar process as the LIVESPO PREG-MOM but contain 5 mL of high-quality RO water from Aquafina.",[15],{"type":32,"name":21,"description":36,"armGroupLabels":37,"otherNames":30},"In Vietnam, LiveSpo Navax is manufactured as a Class-A medical device (Product declaration: No. 210001337\u002FPCBA-HN) in accordance with manufacturing standards approved by the Hanoi Health Department, Ministry of Health, Vietnam (Certificate No. YT117-19), and ISO 13485:2016. LiveSpo Navax product is prepared in the form of NaCl 0.9% plus B. subtilis and B. clausii at 1 billion CFU\u002FmL x 30 mL.\n\nLiveSpo PREG-MOM has a registration number 7695\u002F2020\u002FĐKSP issued by the Food Safety Department of the Ministry of Health in Vietnam.",[21],[39,43],{"name":40,"affiliation":41,"role":42},"Loc V Nguyen, MD.","Phu Tho Provincial Obstetrics and Pediatrics Hospitals","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":46},"Anh TV Nguyen, Assoc. Prof","Spobio Research Center, Anabio R&D","STUDY_CHAIR",[48,52],{"name":40,"role":49,"phone":50,"phoneExt":30,"email":51},"CONTACT","+84986911091","drlocnhi@gmail.com",{"name":53,"role":49,"phone":54,"phoneExt":30,"email":55},"Cong M Nguyen, MD.","+84981241023","congminh.dhyd@gmail.com",[57],{"facility":41,"status":30,"city":58,"state":30,"zip":30,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Phú Thọ","Vietnam","VN",{"type":62,"coordinates":63},"Point",[64,65],105.22221,21.39963,{"lat":65,"lon":64},[68,69,70],{"name":40,"role":49,"phone":50,"phoneExt":30,"email":51},{"name":53,"role":49,"phone":54,"phoneExt":30,"email":55},{"name":40,"role":42,"phone":30,"phoneExt":30,"email":30},{"type":72,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100623675","assessing-role-of-probiotics-in-children-aged-6-36-months-treated-for-pneumonia-100623675",false,"NCT07399717","Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia","Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia at Phu Tho Provincial Obstetrics and Pediatrics Hospitals Within 2026-2027","Inclusion Criteria:\n\n* Children (male\u002Ffemale) aged 6-36 months diagnosed and hospitalized for treatment for pneumonia.\n* Parents or guradians of the children agree to participate in the study, explain, and sign the research consent form.\n\nExclusion Criteria:\n\n* Children who need ventilator support.\n* Children who have had rhinoplasty surgery, nasal ulcers, nasal polyps or any nasal deformity that affects the use of the study product.\n* Children who get transferred or leave the treatment unit (not for professional reasons).\n* Children who have experienced congenital immunodeficiency or infectious disease (eg, HIV).\n* Children who are concurrently participating in another clinical trial or participated in a clinical trial within 30 days before selection.\n* Children who are under long-term medication (more than 7 consecutive days) within 30 days before selection.\n* Children with allergy or hypersensitivity to any ingredient of the study product.","ALL","6 Months","36 Months",{"count":84,"type":85},330,"ESTIMATED","INTERVENTIONAL",[88],"NA","The main questions this study aims to answer are:\n\n* Does using probiotic nasal spray (LiveSpo Navax containing Bacillus subtilis and Bacillus clausii, 1x10\\^9 CFU\u002FmL), with or without oral probiotics (LiveSpo Pregmom containing Bacillus subtilis, Bacillus clausii, and Bacillus coagulans, 3x10\\^9 CFU\u002F5 mL), help children recover better from pneumonia when added to standard medical treatment?\n* Does using these adjunctive probiotics support reduce the recurrence of respiratory and gastrointestinal symptoms after hospital discharge? Researchers will compare three groups of children to see whether probiotic nasal spray alone or probiotic nasal spray combined with oral probiotics works better than placebo.\n\nAll participants will receive standard medical treatment for pneumonia. In addition, they will be randomly assigned to one of three study groups to receive adjunctive probiotic support in 2 months:\n\n* Control group: receives a saline nasal-throat spray (0.9% NaCl) and oral placebo liquid (RO water).\n* Nasal probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray and oral placebo liquid (RO water).\n* Nasal plus oral probiotic group: receives a probiotic LiveSpo® Navax nasal-throat spray plus LiveSpo® Preg-Mom oral probiotic suspension.\n\nParticipants will:\n\n* Use a nasal-throat spray three times a day.\n* Take an oral liquid twice daily.\n* Start using the study products during their hospital stay and continue for 8 weeks (2 months) from admission.\n* Be followed by the study team during hospitalization and at Day 30 and Day 60 after admission. The probiotic and placebo products look, smell, and taste the same so that neither the parents nor the study staff know which product each child receives.",[91,92],"Pneumonia","Pneumonia in Children",[94,95,96,97,98,99,100,101,102,103],"Acute respiratory infection","Adjunctive Treatment","Prevention","Nasal-oropharyngeal","Probiotic spray","Oral probiotic suspension","Bacillus spores","Children","Respiratory viruses","Bacterial co-infection","NOT_YET_RECRUITING","2026-02-03",{"date":107,"type":108},"2026-02-10","ACTUAL",{"date":110,"type":85},"2026-01-26",{"date":112,"type":85},"2027-12-30",{"name":5,"class":6},1]