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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Scoliosis
• Intervention / Treatment: Dietary supplement: Bifidobacterium breve; Behavioral: Lifestyle Education

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 Our unpublished data show that the abundance of probiotics such as Bifidobacterium breve in the intestines of children with idiopathic scoliosis is reduced, while the levels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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangyang Wang; Phone Number: 13506663458; Email: Xiangyangwang@wmu.edu.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325600
      • The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000
      • Contact: Xiangyang Wang; Phone Number: 13506663458; Email: Xiangyangwang@wmu.edu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bifidobacterium 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 telephone follow-up.	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.
Active Comparator: Lifestyle 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.	Behavioral: Lifestyle Education; A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SAHoWMU-CR2026-08-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No