Adolescent Idiopathic Scoliosis (AIS)NCT07900126
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
Trial summary
This single-center, observational, cross-sectional study aims to investigate the association between fecal calprotectin levels and clinical characteristics in adolescents with idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Jun 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents aged 10-18 years diagnosed with idiopathic scoliosis who attend a specialized scoliosis outpatient clinic and meet the study eligibility criteria.
Who may be able to join
- Adolescents aged 10-18 years with a confirmed diagnosis of idiopathic scoliosis (Cobb angle ≥10°).
- No clinical evidence of acute or chronic infection or significant systemic inflammation.
- No recent infection within the preceding three months.
- No history of gastrointestinal disease or recent antibiotic/probiotic use.
- No previous scoliosis surgery.
- Voluntary participation with appropriate informed consent.
Who cannot join
- Congenital, neuromuscular, or syndromic scoliosis.
- Inflammatory bowel disease, celiac disease, autoimmune or other chronic inflammatory disorders, rheumatological disease, or malignancy.
- Family history of inflammatory bowel disease or celiac disease.
- Recent gastrointestinal symptoms, including diarrhea, gastrointestinal bleeding, unexplained abdominal pain, or weight loss.
- Infection within the preceding three months.
- Use of corticosteroids, NSAIDs, or immunosuppressive medications within the preceding three months.
- Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association of Fecal Calprotectin With Curve Severity, Nutritional Status, and Body Composition in Adolescent Idiopathic Scoliosis
This single-center, observational, cross-sectional study aims to investigate the association between fecal calprotectin levels and clinical characteristics in adolescents with idiopathic scoliosis. Clinical, radiological, anthropometric, nutritional, and laboratory parameters will be evaluated to explore potential relationships with curve severity.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Spinal Deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Fecal Calprotectin Levels and Cobb Angle
Fecal calprotectin levels (µg/g) will be measured and their association with radiographic Cobb angle (degrees) will be evaluated.
Measured: At enrollment (single assessment)
Secondary outcomes (3)
Scoliosis Progression Risk Index
Association of fecal calprotectin levels with the Lonstein-Carlson progression risk index.
Measured: At enrollment (single assessment)
Body Composition Parameters
Association of fecal calprotectin levels with body mass index, fat mass, fat-free mass, and body fat percentage.
Measured: At enrollment (single assessment)
Dietary Habits
Association of fecal calprotectin levels with dietary habits assessed using a standardized questionnaire.
Measured: At enrollment (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 83 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Tuğba Atan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900126
- Sponsor's protocol ID
- 126S481
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Fecal Calprotectin With Curve Severity, Nutritional Status, and Body Composition in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07900126
- Acronym / sponsor ID
- 126S481
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Keywords
- Spinal Deformity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 28 Oct 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.
This single-center, observational, cross-sectional study aims to investigate the association between fecal calprotectin levels and clinical characteristics in adolescents with idiopathic scoliosis. Clinical, radiological, anthropometric, nutritional, and laboratory parameters will be evaluated to explore potential relationships with curve severity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents aged 10-18 years diagnosed with idiopathic scoliosis who attend a specialized scoliosis outpatient clinic and meet the study eligibility criteria.
Key inclusion criteria (6 listed)
- Adolescents aged 10-18 years with a confirmed diagnosis of idiopathic scoliosis (Cobb angle ≥10°).
- No clinical evidence of acute or chronic infection or significant systemic inflammation.
- No recent infection within the preceding three months.
- No history of gastrointestinal disease or recent antibiotic/probiotic use.
- No previous scoliosis surgery.
Key exclusion criteria (7 listed)
- Congenital, neuromuscular, or syndromic scoliosis.
- Inflammatory bowel disease, celiac disease, autoimmune or other chronic inflammatory disorders, rheumatological disease, or malignancy.
- Family history of inflammatory bowel disease or celiac disease.
- Recent gastrointestinal symptoms, including diarrhea, gastrointestinal bleeding, unexplained abdominal pain, or weight loss.
- Infection within the preceding three months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Fecal Calprotectin Levels and Cobb Angle
Time frame: At enrollment (single assessment)
Fecal calprotectin levels (µg/g) will be measured and their association with radiographic Cobb angle (degrees) will be evaluated.
3 secondary outcomes
Scoliosis Progression Risk Index
Time frame: At enrollment (single assessment)
Body Composition Parameters
Time frame: At enrollment (single assessment)
Dietary Habits
Time frame: At enrollment (single assessment)
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant privacy and confidentiality considerations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent Idiopathic Scoliosis (AIS), run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.
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 7 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Tuğba Atan, MD (+9 0 312 291 14 14, tubaatan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Fecal Calprotectin Levels and Cobb Angle (time frame: At enrollment (single assessment)). 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 28 Oct 2026.