About this trial
Articular involvement is the most frequent extra-intestinal manifestation of inflammatory bowel diseases (IBD). IBD-related spondyloarthropathy is mainly characterised by axial involvement (including inflammatory back pain, isolated sacroiliitis and ankylosing spondylitis) but may also be associated with peripheral symptoms (i.e peripheral arthritis, dactylitis and enthesopathy, such as Achilles tendinitis, plantar fasciitis, and chest wall pain). In particular, inflammatory back pain (IBP) is characterised by an insidious onset, improves after exercise but not with rest, and is associated with morning stiffness. Up to now, several criteria sets have been proposed to define IBP. Studies conducted in various populations have confirmed a high sensitivity and specificity for the Berlin criteria. Celiac disease (CD) is an autoimmune systemic disease having among its clinical manifestations frequent symptoms common to rheumatologic diseases. Recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition has been named Non-Celiac Gluten Sensitivity' (NCGS) or Non-celic Wheat Sensitivity (NCWS). The clinical picture of NCWS is characterized by combined gastrointestinal and extra-intestinal or systemic manifestations. Many patients affected with CD and NCWS complain of IBP-like symptoms, which generally improve, together with the other clinical manifestations of the diseases, during a gluten-free diet (GFD). Therefore, the aims of the present study are to investigate 1) the effect of a GFD in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year, and 2) the prevalence of IBP in CD and in NCWS patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
morning stiffness >30 min of duration
improvement in back pain with exercise but not with rest
awakening because of back pain during the second half of the night only
alternating buttock pain.
Disqualifiers
positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa
self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
other previously diagnosed gastrointestinal disorders
other previously diagnosed rheumatic diseases
Trial design
Parallel
Treatments tested in this trial
Gluten free diet
Other interventionThe investigators will evaluate the effect of a gluten free diet (GFD) in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year.
Treatment groups
Trial outcomes
Primary outcomes
Musculoskeletal (back pain) evaluation at baseline and after GFD
Musculoskeletal (back pain) evaluation, from baseline at 12 months of GFD, according to the scores calculated on the basis of Visual Analogue Scales for Musculoskeletal (back pain), taking into account whether the patients adhered or not to the GFD.
Changes in cytokines production from peripheral blood mononuclear (PBMC) at baseline and after GFD
Changes in cytokines production from peripheral blood mononuclear (PBMC), from baseline (i.e. at diagnosis) at 12 months of GFD, taking into account whether the patients adhered or not to the GFD.
Secondary outcomes
Prevalence of IBP in CD and in NCWS patients.
Prevalence of IBP in CD and in NCWS patients.
Sponsors and contacts
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