Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.

Last updated: July 4, 2024
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ankylosing Spondylitis

Treatment

Gluten Diet

Gluten-Free Diet

Clinical Study ID

NCT04274374
PHRC IR 2017 COUDERC
2018-A00309-46
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 corticosteroidinfiltration in the month prior to inclusion,

  • able to follow a GFD and to provide written informed consent and submit to therequirements of the study

Exclusion

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 aprobiotic;

  • are pregnant, breastfeeding,

  • not covered by social security;

  • minors or adults under the protection of the law or under the protection of justice.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Gluten Diet
Phase:
Study Start date:
October 07, 2021
Estimated Completion Date:
March 31, 2026

Study 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

Connect with a study center

  • CHU de Bordeaux

    Bordeaux, 33000
    France

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Active - Recruiting

  • CHU de Grenoble

    Grenoble, 38000
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon, 69000
    France

    Site Not Available

  • CHU de Montpellier

    Montpellier, 34000
    France

    Site Not Available

  • Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin

    Paris, 75000
    France

    Site Not Available

  • CHU de Saint-Etienne

    Saint-Étienne, 42000
    France

    Site Not Available

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