Clinical trial NCT04274374: Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ankylosing Spondyloarthritis
Keywords: spondyloarthritis
ankylosing spondylitis
gluten-free diet
gut microbiota
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: PANZANI
name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
First posted: 2020-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 experimental or control arm. In the experimental arm with receive at least 6 gluten-free breads per day + 200 g of gluten-free penne pasta per week + 6 rice flavor capsules per day. The control arm will receive at least 6 gluten-containing breads per day + 200 g of gluten-containing penne pasta per week + 6 vital gluten-containing capsules per day.

At baseline, the dietician will explain to the patients how to properly follow a GFD during a face-to-face interview. The patient's compliance to the GFD will be evaluated by the dietician at S2, S16, an S24 using an online 3-day alimentary questionnaire.

The bread and penne pasta were chosen for their visual resemblance and similar taste to maximize the blindness of the study. In order to reach the daily amount of gluten in a standard diet (estimated in France between 10 and 15 g/d) in the control arm, each day patients will have to ingest six capsules of vital gluten wheat made for the study. Vital gluten flour is an over-the-counter food supplement used to enrich a protein diet or as a base for making products, such as seitan. Capsules will be made using commercially available vital gluten and contain 0.35 g of gluten per capsule. The total amount of gluten in the control arm will be approximately 10.5 g/day.

After the 16-week GFD, patients will be offered to follow or not follow the GFD according to their own decision for an 8-week open-labelled follow-up period. The study duration for each patient is 24 weeks. The patient recruitment is expected to last 2 years

Eligibility criteria: 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessment of the variation in quality of life evaluated variation inby the Assessment of SpondyloArthritis international Society (ASAS) Health Index
timeFrame: Change from baseline ASAS HI score at 16 weeks
Secondary outcomes:
measure: effects of a 16-week GFD versus placebo diet on the activity of SpA evaluated by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
timeFrame: Change from baseline BASDAI score at 16 weeks
measure: effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the erythrocyte sedimentation rate (ESR).
timeFrame: Change from baseline ESR at 16 weeks
measure: effects of a 16-week GFD versus placebo diet on parameters of inflammation evaluated by the C-reactive protein (CRP)
timeFrame: Change from baseline CRP at 16 weeks
measure: effects of a 16-week GFD versus placebo diet on fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.
timeFrame: Change from baseline FACIT score at 16 weeks
measure: effects of a 16-week GFD versus placebo diet on depression evaluated by the Hospital anxiety and depression scale (HAD)
timeFrame: Change from baseline HAD score at 16 weeks
measure: Variations in the abundance and type of different bacterial species found in the intestinal microbiota for a subgroup of patients
timeFrame: Change from baseline abundance and types of bacteria at 16 weeks
measure: effects of a 16-week GFD versus placebo diet on functional disability asssessed by Bath Ankylosing Spondylitis Functionnal Index (BASFI) questionnaire
timeFrame: Change from baseline BASFI score at 16 weeks and at 24 weeks
measure: effects of a 16-week GFD versus placebo diet on the persistence of fibromyalgia syndrome
timeFrame: Persistence of fibromyalgia syndrome at week 16 and 24 (if present at inclusion)
measure: Evaluation of compliance with the GFD by an interview with the dietician
timeFrame: at week 16
measure: effects of a 16-week GFD versus placebo diet on body mass index (BMI)
timeFrame: Change from baseline BMI at week 16 and 24
measure: effects of a 16-week GFD versus placebo diet on Homeostasis Model Assessment of insulin resistance (HOMA-IR)
timeFrame: Change from baseline insulin resistance at week 16
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Marion Couderc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Couderc M, Pereira B, Schaeverbeke T, Thomas T, Chapurlat R, Gaudin P, Morel J, Dougados M, Soubrier M. 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. BMJ Open. 2020 Nov 20;10(11):e038715. doi: 10.1136/bmjopen-2020-038715.