Idiopathic ScoliosisNCT07466511
Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis
A study testing Bifidobacterium breve and Lifestyle Education in people with Idiopathic Scoliosis, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Bifidobacterium breve and Lifestyle Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, Zhejiang 325000
Wenzhou, Zhejiang, 325600
Xiangyang Wang, 13506663458, Xiangyangwang@wmu.edu.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Bifidobacterium breve, Lifestyle Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium breveDietary supplement
Oral Bifidobacterium breve supplementation, 4.5 × 10^6 CFU daily for 6 months
Lifestyle EducationBehavioural
A standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Bifidobacterium breve; Behavioral: 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. Receives: Behavioral: Lifestyle Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Major Cobb Angle
Major curve magnitude will be measured on standing full-spine radiographs using the standard Cobb method.
Measured: 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.
Measured: Baseline and every 6 months up to 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: Baseline and Month 6
Gastrointestinal Symptoms
Gastrointestinal symptoms and bowel movement frequency will be assessed through structured interview.
Measured: Baseline and Month 6
Serum Bile Acid Levels
Serum bile acid concentrations will be measured using blood samples collected from participants.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Oct 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangyang Wang, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466511
- Sponsor's protocol ID
- SAHoWMU-CR2026-08-103
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium Breve Supplementation on the Onset and Progression of Idiopathic Scoliosis: A Prospective, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07466511
- Acronym / sponsor ID
- SAHoWMU-CR2026-08-103
- Conditions
- Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium breve Supplementation plus Lifestyle Education | Experimental | Dietary Supplement: Bifidobacterium breve, Behavioral: Lifestyle EducationParticipants 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. |
| Lifestyle Education Only | Active comparator | Behavioral: Lifestyle EducationParticipants 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. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium breveOral Bifidobacterium breve supplementation, 4.5 × 10^6 CFU daily for 6 months | Dietary supplement | Bifidobacterium breve Supplementation plus Lifestyle Education |
| Lifestyle EducationA standardized education session delivered at baseline on diet optimization, appropriate exercise, and avoidance of unnecessary antibiotic use. | Behavioural | Bifidobacterium breve Supplementation plus Lifestyle Education, Lifestyle Education Only |
Primary outcome
Change in Major Cobb Angle
Time frame: 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)
Time frame: Baseline and every 6 months up to 24 months
Trunk asymmetry will be assessed using a scoliometer to measure angle of trunk rotation.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium breve and Lifestyle Education in people with Idiopathic Scoliosis, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangyang Wang (13506663458, Xiangyangwang@wmu.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Major Cobb Angle (time frame: Baseline and every 6 months up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.