The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis

NCT07166874 | Recruiting

• 1 other identifier: 20240704
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

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.

Conditions

Ankylosing Spondylitis

Keywords

gluten free diet; intestinal permeability; zonulin; ankylosing spondylitis; cytokine; BASDAI

Outcome Measures

Primary Outcomes (2)

• effects of a 8-week Gluten Free Diet versus placebo diet on fasting serum zonulin levels

  Serum zonulin will be evaluated as a biomarker of intestinal permeability. It will be measured by ELISA(enzyme-linked immunosorbent assay) method.

  Change from baseline serum zonulin at 8 weeks

• effects of a 8-week Gluten Free Diet versus placebo diet on fasting serum LPS levels

  Serum LPS will be evaluated as a biomarker of intestinal permeability. It will be measured by ELISA(enzyme-linked immunosorbent assay) method.

  Change from baseline serum LPS at 8 weeks

Secondary Outcomes (15)

• effects of a 8 week Gluten Free Diet versus placebo diet on the activity of Ankylosing Spondylitis evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

  Change from baseline BASDAI score at 8 weeks

• effects of a 8-week Gluten Free Diet versus placebo diet on functional disability asssessed by Bath Ankylosing Spondylitis Functionnal Index (BASFI) questionnaire

  Change from baseline BASFI score at 8 weeks

• effects of a 8 week Gluten Free Diet versus placebo diet on the quality of life of Ankylosing Spondylitis evaluated by the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).

  Change from baseline ASQoL score at 8 weeks

• effects of a 8-week Gluten Free Diet versus placebo diet on CRP levels

  Change from baseline CRP at 8 weeks

• effects of a 8-week Gluten Free Diet versus placebo diet on ESR levels

  Change from baseline ESR at 8 weeks

Study Arms (2)

Control Group

NO INTERVENTION

In the control arm, patients will continue their eating habits.

Gluten Free Diet

EXPERIMENTAL

Patients in the experimental arm will received a gluten-free diet for 8 weeks.

Behavioral: Gluten Free Diet

Interventions

Gluten Free Diet BEHAVIORAL

Patients in the experimental arm will received a gluten-free diet for 8 weeks.

Gluten Free Diet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (4)

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

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Gülay Sezgin

CONTACT

+902124147171; dytgulaysezgin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: January 31, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)