Informations générales (source: ClinicalTrials.gov)
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 (GlutenSPA)
Interventional
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
octobre 2021
mars 2026
09 juillet 2024
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.
Etablissements
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
AP-HP - Hôpital Cochin | Lise Laclautre | Contact (sur clinicalTrials) | |||
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
CHU de Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Lise Laclautre | Contact (sur clinicalTrials) | |||
CHU de Montpellier - 34000 - Montpellier - France | Lise Laclautre | Contact (sur clinicalTrials) | |||
Hospices Civils de Lyon - 69000 - Lyon - France | Lise Laclautre | Contact (sur clinicalTrials) | |||
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
CHU de Bordeaux - 33000 - Bordeaux - France | Lise Laclautre | Contact (sur clinicalTrials) | |||
CHU de Grenoble - 38000 - Grenoble - France | Lise laclautre | Contact (sur clinicalTrials) | |||
CHU de Saint-Etienne - 42000 - Saint-Étienne - France | Lise Laclautre | Contact (sur clinicalTrials) |
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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.