Effects of a gluten-free diet on quality of life in patients with axial spondyloarthritis
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
This study is testing whether a gluten-free diet can improve the quality of life for people with axial spondyloarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Trial ID | NCT04274374 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a gluten-free diet (GFD) on the quality of life of patients diagnosed with axial spondyloarthritis (SpA). It is a 24-week, randomized, double-blinded, placebo-controlled trial involving 200 participants who will be assigned to either a GFD or a gluten-containing diet. Participants will receive specific dietary products to ensure compliance and will be monitored by a dietician throughout the study. The aim is to provide controlled data on the effects of dietary changes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with axial spondyloarthritis who can adhere to a gluten-free diet and have stable treatment for their condition.
Not a fit: Patients with a history of celiac disease or those currently on any restrictive diets may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life for patients with axial spondyloarthritis through dietary management.
How similar studies have performed: While there is limited controlled data on this specific approach, anecdotal evidence suggests potential benefits of gluten-free diets in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bordeaux and 6 other locations
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
- CHU de Grenoble — Grenoble, France (Not_yet_recruiting)
- Hospices Civils de Lyon — Lyon, France (Not_yet_recruiting)
- CHU de Montpellier — Montpellier, France (Not_yet_recruiting)
- Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin — Paris, France (Not_yet_recruiting)
- CHU de Saint-Etienne — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Marion Couderc, MD — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre, Pharm D
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.