Informations générales (source: ClinicalTrials.gov)

NCT04274374 En recrutement
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
  • Spondylite
  • Pelvispondylite rhumatismale
  • Spondylarthrite
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.
 Voir le détail

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 Recrutement non commencé 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 En recrutement Contact (sur clinicalTrials)
CHU de Montpellier - 34000 - Montpellier - France Lise Laclautre Recrutement non commencé Contact (sur clinicalTrials)
Hospices Civils de Lyon - 69000 - Lyon - France Lise Laclautre Recrutement non commencé 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 Recrutement non commencé Contact (sur clinicalTrials)
CHU de Grenoble - 38000 - Grenoble - France Lise laclautre Recrutement non commencé Contact (sur clinicalTrials)
CHU de Saint-Etienne - 42000 - Saint-Étienne - France Lise Laclautre Recrutement non commencé 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



- 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.