NCT07466511

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2030

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Scoliosis Research Society-22 (SRS-22) Questionnaire Score

    Baseline and every 6 months up to 24 months

  • Gut Microbiota Composition

    Baseline and Month 6

  • Gastrointestinal Symptoms

    Baseline and Month 6

  • Serum Bile Acid Levels

    Baseline and Month 6

Study Arms (2)

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.

Dietary Supplement: Bifidobacterium breveBehavioral: Lifestyle Education

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.

Behavioral: Lifestyle Education

Interventions

Bifidobacterium breveDIETARY_SUPPLEMENT

Oral Bifidobacterium breve supplementation, 4.5 × 10\^6 CFU daily for 6 months

Bifidobacterium breve Supplementation plus Lifestyle Education
Lifestyle EducationBEHAVIORAL

A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use.

Bifidobacterium breve Supplementation plus Lifestyle EducationLifestyle Education Only

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000

Wenzhou, Zhejiang, 325600, China

Location

Central Study Contacts

Xiangyang Wang

CONTACT

13506663458Xiangyangwang@wmu.edu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Chief physician, Doctorial superviso

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations

CN(1)