Status:
RECRUITING
Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
PANZANI
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions:
Ankylosing Spondyloarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 in...
Detailed Description
The GlutenSpA study is a 24-week, randomized, double-blinded, placebo-controlled, multicenter trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an expe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04274374
Start Date
October 7 2021
End Date
March 1 2026
Last Update
July 8 2024
Active Locations (7)
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1
CHU de Bordeaux
Bordeaux, France, 33000
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
3
CHU de Grenoble
Grenoble, France, 38000
4
Hospices Civils de Lyon
Lyon, France, 69000