Inflammatory Back Pain and Gluten Free Diet

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Palermo

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Gluten free diet

    Other intervention

    The 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

50 Participants
are divided into 2 treatment groups
Group A: IBP patients on standard therapyNo intervention 0 interventions
Group B: IBP patients on standard therapy and GFDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline at 12 months
2

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.

Time frame
Change from baseline at 12 months

Secondary outcomes

1

Prevalence of IBP in CD and in NCWS patients.

Prevalence of IBP in CD and in NCWS patients.

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

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