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Search / Trial NCT04274374

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

Launched by UNIVERSITY HOSPITAL, CLERMONT-FERRAND · Feb 14, 2020

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Spondyloarthritis Ankylosing Spondylitis Gluten Free Diet Gut Microbiota

ClinConnect Summary

This clinical trial is studying the effects of a gluten-free diet (GFD) on the quality of life for patients with axial spondyloarthritis, a type of inflammatory arthritis that mainly affects the spine. Many patients with this condition have reported gut issues, and some are already trying gluten-free diets, but there hasn’t been enough scientific research to understand how this diet truly impacts their lives. The goal of this study is to gather reliable data on whether following a GFD can improve the well-being of these patients.

To be eligible for the trial, participants must have a confirmed diagnosis of axial spondyloarthritis and should not have changed their treatment plan in the last few months. They also need to be stable on their current medications, like non-steroidal anti-inflammatory drugs (NSAIDs), for at least three months. Participants will be required to follow a gluten-free diet and provide informed consent to join the study. It’s important to note that individuals with certain conditions, like celiac disease, or those who have recently taken antibiotics or other specific medications, cannot participate. Overall, this trial aims to better understand how dietary changes can affect the lives of those living with axial spondyloarthritis.

Gender

ALL

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.

About University Hospital, Clermont Ferrand

The University Hospital of Clermont-Ferrand is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its multidisciplinary approach, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes collaboration among healthcare professionals, researchers, and academic partners. With a strong commitment to improving patient outcomes, the institution actively engages in a wide array of clinical studies, ranging from early-phase trials to large-scale interventions, aimed at addressing critical health challenges and enhancing treatment modalities. Its state-of-the-art facilities and expertise make it a pivotal contributor to clinical research in the region and beyond.

Locations

Grenoble, , France

Bordeaux, , France

Clermont Ferrand, , France

Bordeaux, , France

Lyon, , France

Montpellier, , France

Saint étienne, , France

Paris, , France

Patients applied

0 patients applied

Trial Officials

Marion Couderc, MD

Principal Investigator

CHU de Clermont-Ferrand

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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