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

ConditionIdiopathic Scoliosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 6 to 15 years

Disqualifiers

Plans to relocate within the next 24 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bifidobacterium breve

    Dietary supplement

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

  • Lifestyle Education

    Behavioral

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Bifidobacterium breve Supplementation plus Lifestyle EducationExperimental treatment 2 interventions
Group B: Lifestyle Education OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Major Cobb Angle

Major curve magnitude will be measured on standing full-spine radiographs using the standard Cobb method.

Time frame
Baseline and every 6 months up to 24 months
2

Change in Angle of Trunk Rotation (ATR)

Trunk asymmetry will be assessed using a scoliometer to measure angle of trunk rotation.

Time frame
Baseline and every 6 months up to 24 months

Secondary outcomes

1

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.

Time frame
Baseline and every 6 months up to 24 months
2

Gut Microbiota Composition

Gut microbial composition in stool samples will be assessed using metagenomic sequencing or polymerase chain reaction methods.

Time frame
Baseline and Month 6
3

Gastrointestinal Symptoms

Gastrointestinal symptoms and bowel movement frequency will be assessed through structured interview.

Time frame
Baseline and Month 6
4

Serum Bile Acid Levels

Serum bile acid concentrations will be measured using blood samples collected from participants.

Time frame
Baseline and Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Wenzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: