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Clinical Trial NCT07466511 for Idiopathic Scoliosis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis 100
Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
- SAHoWMU-CR2026-08-103
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBifidobacterium breve Supplementation plus Lifestyle Education 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 telep...Show More | Bifidobacterium breve Oral Bifidobacterium breve supplementation, 4.5 × 10\^6 CFU daily for 6 months Lifestyle Education A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use. |
Active ComparatorLifestyle Education Only 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. | Lifestyle Education A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Major Cobb Angle | Major curve magnitude will be measured on standing full-spine radiographs using the standard Cobb method. | Baseline and every 6 months up to 24 months |
Change in Angle of Trunk Rotation (ATR) | Trunk asymmetry will be assessed using a scoliometer to measure angle of trunk rotation. | Baseline and every 6 months up to 24 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Scoliosis Research Society-22 (SRS-22) Questionnaire Score | Health-related quality of life will be assessed using the SRS-22 questionnaire, including pain, self-image, function, mental health, and treatment satisfaction. | Baseline and every 6 months up to 24 months |
Gut Microbiota Composition | Gut microbial composition in stool samples will be assessed using metagenomic sequencing or polymerase chain reaction methods. | Baseline and Month 6 |
Gastrointestinal Symptoms | Gastrointestinal symptoms and bowel movement frequency will be assessed through structured interview. | Baseline and Month 6 |
Serum Bile Acid Levels | Serum bile acid concentrations will be measured using blood samples collected from participants. | Baseline and Month 6 |
- Age 6 to 15 years
Diagnosed with idiopathic scoliosis based on clinical evaluation and radiographic examination at the first clinic visit
Skeletally immature, defined as Risser sign 0 to 3
Major Cobb angle < 40 degrees at baseline
Written informed consent provided by the participant or legal guardian
Able and willing to comply with study procedures
- Plans to relocate within the next 24 months
Use 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
Known allergy, sensitivity, or intolerance to the investigational product or its ingredients
Current or prior significant gastrointestinal disease requiring medication, or history of gastrointestinal surgery
Severe gastrointestinal symptoms such as persistent heartburn or indigestion
Musculoskeletal, neurodevelopmental, syndromic, or other conditions that may account for the spinal deformity
History of spine surgery or major spinal injury
Spinal tumor or malignant disease involving the spine
Leg length discrepancy > 20 mm
Severe chronic diseases that could interfere with study participation or outcome assessment, including but not limited to diabetes, narcolepsy, or poorly controlled asthma
Severe obesity, defined as BMI z-score ≥ 3
Second Affiliated Hospital of Wenzhou Medical UniversityZhejiang