Gluten-free diet effects in people with ankylosing spondylitis
The Impacts of Gluten Free Diet on Disease Activity, Quality of Life and Intestinal Permeability in Patients Diagnosed With Ankylosing Spondylitis.
This will try an 8-week gluten-free diet to see if it reduces gut leakiness and improves symptoms and function in adults with ankylosing spondylitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 4 sites (Istanbul and 3 other locations) |
| Trial ID | NCT07166874 on ClinicalTrials.gov |
What this trial studies
Adults with axial spondyloarthritis (ankylosing spondylitis) will follow an 8-week gluten-free diet and be compared to a control group with clinical and laboratory measurements taken before and after the intervention. Investigators will measure intestinal permeability markers (including zonulin), circulating lipopolysaccharide (LPS), signs of subclinical intestinal inflammation, disease activity scores, functional status, and quality of life. Eligible participants are 18–64 years old, on stable NSAID and/or DMARD therapy for at least three months, and must not be on a restrictive diet or have excluded comorbidities. The study involves outpatient visits at Istanbul hospitals for biomarker sampling and clinical assessments.
Who should consider this trial
Good fit: Adults aged 18–64 with axial SpA/ankylosing spondylitis meeting ASAS criteria who are on stable NSAID and/or DMARD treatment for ≥3 months, not currently on a special diet, and willing to follow an 8-week gluten-free plan are ideal candidates.
Not a fit: People with diagnosed celiac disease, inflammatory bowel disease, irritable bowel syndrome, diabetes, Hashimoto thyroiditis, pregnancy or breastfeeding, those with BMI outside the 18.50–29.99 kg/m2 range, or those already following restrictive diets are not eligible and therefore would not receive benefit from this protocol.
Why it matters
Potential benefit: If successful, a gluten-free diet could strengthen the intestinal barrier, reduce systemic inflammation, and lead to symptom and functional improvement for some people with ankylosing spondylitis.
How similar studies have performed: There are some indirect reports and observational suggestions that gluten restriction may help spondyloarthritis symptoms, but no prior trials have directly tested the zonulin→LPS intestinal-permeability mechanism in ankylosing spondylitis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of axial SpA defined by ASAS criteria * Adults (aged 18-64 years) * stable treatment (NSAID and/or DMARD) for at least 3 months * provide written informed consent and submit to the requirements of the study Exclusion Criteria: * Any diet at the time of inclusion or within 3 months prior to inclusion; * have a history of celiac disease; * have a history of Ulcerative Colitis, Crohn's Disease and Irritable Bowel Syndrom * patients with Type 1 and Type 2 Diabetes Mellitus * patients with Hashimoto Thyroiditis * are pregnant, breastfeeding, * patients who have used omega-3 and vitamins (A, C, E) regularly in the last 3 months. * BMI \<18,50 kg/m2 * BMI ≥29,99 kg/m2
Where this trial is running
Istanbul and 3 other locations
- Bakırköy Dr. Sadi Konuk Training and Research hospital — Istanbul, Turkey (Türkiye) (Recruiting)
- İstanbul Medeniyet University — Istanbul, Turkey (Türkiye) (Active_not_recruiting)
- İstanbul Sağlık Bilimleri University — Istanbul, Turkey (Türkiye) (Active_not_recruiting)
- Marmara University — Istanbul, Turkey (Türkiye) (Active_not_recruiting)
Study contacts
- Study coordinator: Gülay Sezgin
- Email: dytgulaysezgin@gmail.com
- Phone: +902124147171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.