[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640203":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":33,"responsibleParty":62,"collaborators":18,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":18,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":18,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":91,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic Intervention Group","EXPERIMENTAL","Preterm infants in this group will receive standard care plus a daily oral probiotic mixture for 6 months.",[13],"Dietary Supplement: Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","NO_INTERVENTION","Preterm infants in this group will receive routine neonatal follow-up and standard infant feeding practices without additional probiotic supplementation for 6 months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DIETARY_SUPPLEMENT","Probiotic Mixture (Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG)","Daily oral administration of a probiotic mixture containing Bifidobacterium animalis subsp. lactis Bb-12 and Lacticaseibacillus rhamnosus LGG at a dose of 3 x 10\\^9 CFU\u002Fday for 6 months.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"WenXian Wang, Doctor","CONTACT","+86 13816964779","24111020016@m.fudan.edu.cn",{"name":32,"role":28,"phone":18,"phoneExt":18,"email":18},"Gengsheng He, PhD",[34],{"facility":35,"status":18,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Shanghai Children's Hospital","Shanghai","Shanghai Municipality","200062","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48,50,52,55,57,60],{"name":49,"role":28,"phone":29,"phoneExt":18,"email":30},"WenXian Wang, MD",{"name":51,"role":28,"phone":18,"phoneExt":18,"email":18},"Jinjin Chen, Professor",{"name":53,"role":54,"phone":18,"phoneExt":18,"email":18},"WenXian WANG, MD","PRINCIPAL_INVESTIGATOR",{"name":56,"role":54,"phone":18,"phoneExt":18,"email":18},"Gengsheng He, Professor",{"name":58,"role":59,"phone":18,"phoneExt":18,"email":18},"YuWei Liu, Professor","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":18,"phoneExt":18,"email":18},"LiMing Wen, Professor",{"type":54,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Gengsheng He","Professor","100640203","probiotics-supplementation-for-neurodevelopment-in-preterm-infants-100640203",false,"NCT07617181","Probiotics Supplementation for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)\n* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).\n* Corrected age of 6 months ± 7days at the time of enrollment.\n* No systemic antibiotic usage within 14 days prior to screening.\n* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.\n\nExclusion Criteria:\n\n* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).\n* Severe neurological disorders or structural brain injuries (e.g., Grade III\u002FIV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).\n* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).\n* Concurrent participation in other interventional clinical trials.\n* Planned long-term use of other commercial probiotic\u002Fprebiotic supplements outside the study protocol during the intervention period.\n* High risk of loss to follow-up (e.g., expected relocation).","ALL","23 Weeks","25 Weeks",{"count":76,"type":77},116,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids \\[SCFAs\\], and systemic inflammatory markers.",[83,84,85],"Premature Birth","Neurodevelopmental Disorders","Dysbiosis",[87,88,89,90],"Probiotics","Gut-Brain Axis","Neonatal Antibiotic Exposure","Preterm Infants","NOT_YET_RECRUITING","2026-05-23",{"date":94,"type":95},"2026-06-01","ACTUAL",{"date":97,"type":77},"2026-06",{"date":99,"type":77},"2027-12",{"name":5,"class":6},1]