The Impacts of Gluten-free Diet in Patients With Ankylosing Spondylitis
ConditionAnkylosing Spondylitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorSaglik Bilimleri Universitesi
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Gluten Free Diet
BehavioralPatients in the experimental arm will received a gluten-free diet for 8 weeks.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Gluten Free DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline serum zonulin at 8 weeks2
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.
Time frame
Change from baseline serum LPS at 8 weeksSecondary outcomes
1
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).
The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease,
Time frame
Change from baseline BASDAI score at 8 weeks2
effects of a 8-week Gluten Free Diet versus placebo diet on functional disability asssessed by Bath Ankylosing Spondylitis Functionnal Index (BASFI) questionnaire
Functional disability index consisting of 10 questions. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions. The higher the score, the greater the handicap.
Time frame
Change from baseline BASFI score at 8 weeks3
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).
It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).
Time frame
Change from baseline ASQoL score at 8 weeks4
effects of a 8-week Gluten Free Diet versus placebo diet on CRP levels
A c-reactive protein test measures the level of c-reactive protein (CRP) in your blood. CRP is a protein made by your liver. It's sent into your bloodstream in response to inflammation. Normally, you have low levels of c-reactive protein in your blood. High levels may be sign of a serious infection or other disorder.
Time frame
Change from baseline CRP at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov