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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU de Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
Hospices Civils de Lyon
NOT_YET_RECRUITING
Lyon
CHU de Montpellier
NOT_YET_RECRUITING
Montpellier
Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin
NOT_YET_RECRUITING
Paris
CHU de Saint-Etienne
NOT_YET_RECRUITING
Saint-etienne
Contact Information
Primary
Lise Laclautre, Pharm D
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Time Frame
Start Date: 2021-10-07
Estimated Completion Date: 2026-03
Participants
Target number of participants: 200
Treatments
Experimental: experimental arm
In the experimental arm will receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day
Active_comparator: control arm
the control arm will received 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day
Sponsors
Collaborators: PANZANI, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Leads: University Hospital, Clermont-Ferrand

This content was sourced from clinicaltrials.gov