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Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis

NCT07466511 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2027-01-01
Last updated
2026-03-12

Condition(s) studied

Idiopathic Scoliosis

Investigational drug(s) / intervention(s)

Bifidobacterium breveLifestyle Education

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in Major Cobb Angle — Baseline and every 6 months up to 24 months
    Major curve magnitude will be measured on standing full-spine radiographs using the standard Cobb method.
  • Change in Angle of Trunk Rotation (ATR) — Baseline and every 6 months up to 24 months
    Trunk asymmetry will be assessed using a scoliometer to measure angle of trunk rotation.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000 Wenzhou Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07466511 on ClinicalTrials.gov ↗ ← All trials in China