Inflammatory Back Pain and Gluten Free Diet

Starting soon · Not applicable

Conditions studied: Inflammatory Back Pain

In brief

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.

Key facts

Study ID: NCT03017716
Run by: University of Palermo
People needed: 50
Starts: 2026-07-01
Expected to finish: 2028-01-01
Last updated by the study team: 2026-01-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To diagnose IBP the standard Berlin Criteria will be adopted. IBP is defined by at least 2 positive responses among four items:
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.
To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:
positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
presence of intestinal villous atrophy.
To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
absence of intestinal villous atrophy
negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection)
resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms
symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too.

You may not qualify if…

Exclusion criteria for NCWS diagnosis will be:
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
nervous system disease and/or major psychiatric disorder
physical impairment limiting physical activity.

Where it is running

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca — Sciacca, Agrigento, Italy
Department of Internal Medicine, University Hospital of Palermo — Palermo, Palermo, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.