RecruitingNAINTERVENTIONAL

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

This study is investigating whether eating a gluten-free diet can make a difference for people living with axial spondyloarthritis, a type of inflammatory arthritis affecting the spine. Doctors have noticed that some patients with this condition are trying gluten-free diets, even though there isn't much research to show if it helps. This study aims to find out if removing gluten from your diet can improve your overall well-being and daily life. Participants will follow a diet for several weeks, some with gluten and some without, to compare the effects on their quality of life. The study will last 24 weeks for each person involved.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Clermont-Ferrand

Enrolment target

200

Start

07 Oct 2021

Estimated completion

01 Mar 2026

Ankylosing Spondyloarthritis

What is this study about?

This study is all about a condition called axial spondyloarthritis (say: ank-sial spon-dih-lo-ar-THRY-tis), which is a long-term type of arthritis that mainly affects the spine. People with this condition often experience pain and stiffness. Some researchers have found clues that there might be a connection between bowel problems and this condition, and this has led some patients to try a gluten-free diet, similar to what people with coeliac disease might follow.

However, doctors don't currently have strong evidence from official studies to recommend a gluten-free diet for everyone with axial spondyloarthritis. That's why this research is so important. It aims to provide clear answers about whether changing to a gluten-free diet can actually improve how people with this condition feel and their everyday quality of life.

The study involves two groups of people: one group will eat a gluten-free diet, and the other will continue to eat foods with gluten. The researchers will then compare how both groups' quality of life changes over time. By doing this, they hope to understand if a gluten-free diet is a helpful approach for managing axial spondyloarthritis and improving patients' overall well-being.

Key takeaways

This study explores if a gluten-free diet helps people with axial spondyloarthritis.
It's a controlled study comparing a gluten-free diet with a gluten-containing diet.
Participation lasts 24 weeks, with 16 weeks on a specific diet.
The study provides special foods and capsules for participants.
Neither you nor the researchers will know your diet group for the main part of the study.
The aim is to understand the impact of diet on quality of life for patients.

Who may be eligible?

To join this study, you need to have a diagnosis of axial spondyloarthritis. Your specialist doctor (rheumatologist) must agree that your current treatment shouldn't change for at least four months after you join. Your medication for the condition, such as NSAIDs or DMARDs, should have been stable for at least three months, and you shouldn’t have had any steroid injections in the month before starting.

It's important that you are able and willing to follow a gluten-free diet if you are asked to. You also need to be able to understand the study and agree in writing to take part. You must be aged 18 or over and be covered by social security.

You cannot join if you are already on a special diet, for example, a gluten-free diet, or have been in the last three months. You also can't take part if you have a history of coeliac disease, have recently taken antibiotics (in the last three months), or are taking probiotics. Pregnant or breastfeeding women also cannot participate. Finally, people who are under 18 or adults who are legally unable to make decisions for themselves are not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have been diagnosed with axial spondyloarthritis.
My specialist doctor thinks my current treatment is stable and won't change soon.
I haven't had a steroid injection in the last month or taken antibiotics in the last three months.
I'm not pregnant or breastfeeding.
I don't have coeliac disease and haven't tried a special diet recently.
I am 18 years old or older.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be in the study for a total of 24 weeks. For the first 16 weeks, you'll be asked to follow a specific diet. Half of the participants will receive special gluten-free foods (like bread and pasta) and capsules without gluten. The other half will receive similar-looking foods and capsules, but these will contain gluten. Neither you nor the study staff will know which diet you are on during these 16 weeks.

A dietitian will meet with you at the start to explain how to follow your assigned diet. To check how well you're sticking to the diet, you'll be asked to complete an online questionnaire about what you've eaten over three days, specifically at weeks 2, 16, and 24. The study will provide you with the special bread, pasta, and capsules.

After the 16-week special diet period, you'll have an 8-week 'open-label' follow-up. During this time, you can decide whether you want to continue following a gluten-free diet or not, based on what you feel is best for you. No specific clinic visits are mentioned beyond the initial dietitian meeting and the online questionnaires.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as gaining a better understanding of how diet could affect your axial spondyloarthritis. The information gathered may also help others with the same condition in the future. There are some potential risks: if you are in the gluten-free group, you might find it challenging to stick to the diet, and if you are in the gluten-containing group, there's always a chance that gluten might not agree with you (though the study aims to reflect an average diet). You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

CHU de Bordeaux
Verified postcode
Bordeaux, France· Not yet recruiting
CHU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
CHU de Grenoble
Verified postcode
Grenoble, France· Not yet recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Not yet recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Not yet recruiting
Assistance Publique - Hôpitaux de Paris (AP-HP) - Hôpital Cochin
Verified postcode
Paris, France· Not yet recruiting
CHU de Saint-Etienne
Verified postcode
Saint-Etienne, France· Not yet recruiting

Common questions

What is axial spondyloarthritis?

It's a type of inflammatory arthritis that mainly causes pain and stiffness in your spine and joints.

What does 'gluten-free' mean?

It means avoiding foods that contain gluten, a protein found in wheat, barley, and rye.

Will I know if I'm eating gluten or not?

For the first 16 weeks, neither you nor the study staff will know which diet group you are in; it's a 'blinded' study.

How long will I be in the study?

Each participant will be in the study for a total of 24 weeks.

Do I have to pay for the special foods or capsules?

No, the study will provide you with the special bread, pasta, and capsules needed for your diet group.

How to find out more

Lise Laclautre, Pharm D

promo_interne_drci@chu-clermontferrand.fr 334.73.754.963 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.