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New treatment option for Ankylosing Spondyloarthritis
Official title Impact of a Gluten-free Diet on Quality of Life in Patients With Axial Spondyloarthritis.
ClinicalTrials.gov ID: NCT04274374
What this study is testing
- What it's testing
- 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.
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Clermont-Ferrand, France
- Grenoble, France
- Lyon, France
- Montpellier, France
- Paris, France
- Saint-Etienne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Clermont-Ferrand, France; Grenoble, France; Lyon, France; Montpellier, France; Paris, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.