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Association between Genetic Variants, Gut Microbiota, and Biomechanics in Adolescent Idiopathic Scoliosis (AIS) – A Controlled Study

Association between Genetic Variants, Gut Microbiota, and Biomechanics in Adolescent Idiopathic Scoliosis (AIS) – A Controlled Study Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124596
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Adolescent idiopathic scoliosis patients:none
Parents of adolescents with idiopathic scoliosis:none
Adolescent healthy control group:none
Parents of the adolescent healthy control group:none

Sponsors

Tai'an Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Scoliosis Group: 1. Aged 10-18 years, regardless of gender; diagnosed with AIS by EOS full-spine imaging, with a Cobb angle >= 20° and Risser sign 0-2 (skeletally immature); 2. No history of spinal surgery, brace treatment, or long-term antibiotic use (in the past 3 months); 3. Patients and their parents voluntarily participate, sign the informed consent form, and can cooperate with sample collection and follow-up. Inclusion Criteria for the Healthy Group: 1. Aged 10 to 17 years, with gender and BMI matched to the case group, and no family history of spinal-related diseases. 2. Physical examination or EOS full-spine imaging shows a Cobb angle <10°, without spinal deformity or related symptoms. 3. No family history of AIS or other musculoskeletal diseases. 4. No history of antibiotic use in the past 3 months, voluntary participation and signed informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria for Scoliosis Group: 1. Non-idiopathic scoliosis (such as congenital, neuromuscular, and syndromic types); combined with severe cardiopulmonary diseases, neurological diseases, immunodeficiency diseases, or malignant tumors; 2. Use of antibiotics, probiotics, glucocorticoids, and other drugs that affect intestinal flora or bone metabolism in the past 3 months; history of gastrointestinal surgery, intestinal diseases such as chronic diarrhea/constipation; 3. Lower limb length discrepancy > 1cm, severe foot and ankle deformities (affecting biomechanical assessment); 4. Parents with a history of spinal surgery or severe spinal deformities; those who cannot cooperate with sample collection or follow-up. Exclusion Criteria for the Healthy Group: 1. Same as the case group (excluding the confirmed diagnostic criteria related to AIS).

Design outcomes

Primary

MeasureTime frame
Serum metabolites;Intestinal flora sequencing;Plantar pressure;balance function;Gait parameters;Spinal imaging;22-Item Questionnaire Scale of the Scoliosis Research Society;

Countries

China

Contacts

Public ContactZheng Zuncheng

Tai'an Central Hospital

zhengzc1965@126.com+86 133 7538 8062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026