NCT07166874 The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis
| NCT ID | NCT07166874 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Saglik Bilimleri Universitesi |
| Condition | Ankylosing Spondylitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-31 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Subclinical intestinal inflammation and intestinal permeability have been reported in patients with ankylosing spondylitis. Gluten is one of the main triggers of zonulin releaseand gluten intake may contribute to the development of the disease by increasing intestinal permeability. This study aims to determine the impacts of a gluten-freediet on intestinal permeability, sub-clinical intestinal inflammation, disease activity, functional status and quality of life in patients with ankylosing spondylitis. The main questions it aims to answer are: Does a gluten-free diet have an effect on disease activity and functional status in patients with ankylosing spondylitis? Does a gluten-free diet have an effect on intestinal permeability and subclinical intestinal inflammation in patients with ankylosing spondylitis? The investigators will evaluate the effects of the gluten-free diet compared to a control group.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07166874 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Ankylosing Spondylitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07166874 currently recruiting?
Yes, NCT07166874 is actively recruiting participants. Contact the research team at dytgulaysezgin@gmail.com for enrollment information.
Where is the NCT07166874 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07166874 clinical trial?
NCT07166874 is sponsored by Saglik Bilimleri Universitesi. The trial plans to enroll 60 participants.