GlutenSpA trial: protocol for a randomised double-blind placebo-controlled trial of the impact of a gluten-free diet on quality of life in patients with axial spondyloarthritis.

ABSTRACT:

Introduction

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.

Methods and analysis

The GlutenSpA study is a 24-week, randomised, double-blinded, placebo-controlled, multicentre trial. Patients with axial SpA (n=200) will follow a 16-week GFD and be randomly assigned (1:1) to an experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne past

SUBMITTER: Couderc M 

PROVIDER: S-EPMC7682451 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature