Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bifidobacterium breve, Lifestyle Education.
- Who it may be relevant to
- Registry conditions: Idiopathic Scoliosis. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
Overview
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.
Detailed description
Idiopathic scoliosis (IS) is a common pediatric disorder characterized by a spinal curvature exceeding 10 degrees that develops in the absence of obvious congenital or physiological defects. IS is highly prevalent during adolescence, afflicting 3-4% of children worldwide, yet the underlying causes remain poorly understood. Recent studies have indicated that children with idiopathic scoliosis have a disrupted gut microbiota, but there is currently no clinical data on the impact of any probiotic supplementation on scoliosis. Our unpublished data show that the abundance of probiotics such as Bifidobacterium breve in the intestines of children with idiopathic scoliosis is reduced, while the levels of multiple bile acids in the blood are elevated. Therefore, we hypothesize that Bifidobacterium breve supplementation can reduce the progression rate of idiopathic scoliosis in children and may have a potential role in preventing the onset of new cases of scoliosis in children.
This study is a single-blind, randomized controlled trial to investigate the effect of Bifidobacterium breve on the magnitude of idiopathic spinal curves. Eligible scoliosis children will be randomly assigned to one of two groups. The intervention group will receive oral supplementation of Bifidobacterium breve at 4.5x106 CFU daily for 6 months, along with a standardized gut microbiota-related health course for lifestyle correction (such as adjusting diet, moderate exercise, and reducing antibiotic abuse). The intervention group will be subject to regular phone follow-ups to inquire about probiotic intake and be encouraged to adhere to the regimen. The control group will receive the same health course but no probiotic supplementation, serving as an active control to account for the impact of lifestyle improvements. For all scoliosis children, routine follow-up visits will be scheduled every 6 months for at least 24 months to assess curve progression. Additionally, children who have not yet reached the scoliosis threshold at baseline will also be invited and randomly assigned to the same grouping scheme or simply followed up as observational subjects. All participating children, as part of a provincial health program in Zhejiang Province, will undergo annual scoliosis screening and clinical assessment.
Interventions
- Dietary supplement Bifidobacterium breve
Oral Bifidobacterium breve supplementation, 4.5 × 10\^6 CFU daily for 6 months - Behavioral Lifestyle Education
A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use.
Primary outcome measures
- Change in Major Cobb Angle [Time frame: Baseline and every 6 months up to 24 months]
- Change in Angle of Trunk Rotation (ATR) [Time frame: Baseline and every 6 months up to 24 months]
Secondary outcome measures (4)
- Scoliosis Research Society-22 (SRS-22) Questionnaire Score [Time frame: Baseline and every 6 months up to 24 months]
- Gut Microbiota Composition [Time frame: Baseline and Month 6]
- Gastrointestinal Symptoms [Time frame: Baseline and Month 6]
- Serum Bile Acid Levels [Time frame: Baseline and Month 6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000 — Wenzhou
Identifiers
NCT: NCT07466511 · SAHoWMU-CR2026-08-103