[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628812":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":26,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Bifidobacterium breve Supplementation plus Lifestyle Education","EXPERIMENTAL","Participants in this arm will receive oral Bifidobacterium breve supplementation at a dose of 4.5 × 10\\^6 CFU daily for 6 months, together with a one-time standardized lifestyle education session at baseline. The education program will include guidance on healthy diet, appropriate physical activity, and avoidance of unnecessary antibiotic use. Adherence to probiotic supplementation will be reinforced by regular telephone follow-up.",[13,14],"Dietary Supplement: Bifidobacterium breve","Behavioral: Lifestyle Education",{"label":16,"type":17,"description":18,"interventionNames":19},"Lifestyle Education Only","ACTIVE_COMPARATOR","Participants in this arm will receive the same standardized lifestyle education session and study materials as the experimental group, but no probiotic supplementation will be provided.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Bifidobacterium breve","Oral Bifidobacterium breve supplementation, 4.5 × 10\\^6 CFU daily for 6 months",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Lifestyle Education","A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use.",[9,16],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Xiangyang Wang","CONTACT","13506663458","Xiangyangwang@wmu.edu.com",[39],{"facility":40,"status":26,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000","Wenzhou","Zhejiang","325600","China","CN",{"type":47,"coordinates":48},"Point",[49,50],120.66682,27.99942,{"lat":50,"lon":49},[53],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},{"type":55,"investigatorFullName":34,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","M.D., Chief physician, Doctorial superviso","100628812","effect-of-bifidobacterium-breve-supplementation-on-the-onset-and-progression-of-idiopathic-scoliosis-100628812",false,"NCT07466511","Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis","Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 6 to 15 years\n\nDiagnosed with idiopathic scoliosis based on clinical evaluation and radiographic examination at the first clinic visit\n\nSkeletally immature, defined as Risser sign 0 to 3\n\nMajor Cobb angle \\\u003C 40 degrees at baseline\n\nWritten informed consent provided by the participant or legal guardian\n\nAble and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Plans to relocate within the next 24 months\n\nUse of antibiotics, probiotics, hormones, immunosuppressants, or other nutritional supplements known to affect gut microbiota within the past 3 months or during the study period without investigator approval\n\nKnown allergy, sensitivity, or intolerance to the investigational product or its ingredients\n\nCurrent or prior significant gastrointestinal disease requiring medication, or history of gastrointestinal surgery\n\nSevere gastrointestinal symptoms such as persistent heartburn or indigestion\n\nMusculoskeletal, neurodevelopmental, syndromic, or other conditions that may account for the spinal deformity\n\nHistory of spine surgery or major spinal injury\n\nSpinal tumor or malignant disease involving the spine\n\nLeg length discrepancy \\> 20 mm\n\nSevere chronic diseases that could interfere with study participation or outcome assessment, including but not limited to diabetes, narcolepsy, or poorly controlled asthma\n\nSevere obesity, defined as BMI z-score ≥ 3","ALL","6 Years","15 Years",{"count":68,"type":69},100,"ESTIMATED","INTERVENTIONAL",[72],"NA","Researchers hypothesized that Bifidobacterium breve Supplement could reduce the progression rate of idiopathic scoliosis in children and potentially prevent the occurrence of new cases of scoliosis.",[75],"Idiopathic Scoliosis","NOT_YET_RECRUITING","2026-03-09",{"date":79,"type":80},"2026-03-12","ACTUAL",{"date":82,"type":69},"2027-01-01",{"date":84,"type":69},"2030-12-31",{"name":5,"class":6},1]