Gluten-free diet effects in people with ankylosing spondylitis
Official title: The Impacts of Gluten Free Diet on Disease Activity, Quality of Life and Intestinal Permeability in Patients Diagnosed With Ankylosing Spondylitis.
Run by Saglik Bilimleri Universitesi · NCT07166874 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Saglik Bilimleri Universitesi Academic / other |
| Locations | 4 sites (Istanbul and 3 other locations) |
| Status | Recruiting |
| Started | January 31, 2025 |
| Main results expected | December 30, 2025 |
| Study ends | May 31, 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT07166874 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.