Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.
Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis: Study Protocol of a Randomized Double-blind Placebo-controlled Trial
University Hospital, Clermont-Ferrand
200 participants
Oct 7, 2021
INTERVENTIONAL
Conditions
Summary
Subclinical intestinal inflammation and gut dysbiosis have been reported in patients with spondyloarthritis (SpA). In common practice, rheumatologists are increasingly confronted with patients with inflammatory rheumatism who are on gluten-free diets (GFDs), despite the lack of reliable data from controlled studies. This study aims to determine the impact of a GFD on the quality of life of patients with axial SpA.
Eligibility
Inclusion Criteria4
- diagnosis of axial SpA defined by ASAS criteria
- Rheumatologist not wish to change the treatment within 4 months of inclusion,
- stable treatment (NSAID and/or DMARD) for at least 3 months but no corticosteroid infiltration in the month prior to inclusion,
- able to follow a GFD and to provide written informed consent and submit to the requirements of the study
Exclusion Criteria6
- Any diet at the time of inclusion or within 3 months prior to inclusion;
- have a history of celiac disease;
- received antibiotic treatment within 3 months of inclusion or are taking a probiotic;
- are pregnant, breastfeeding,
- not covered by social security;
- minors or adults under the protection of the law or under the protection of justice.
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Interventions
Dietary supplement without gluten
Dietary supplement with gluten
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04274374