Inflammatory Back Pain Clinical Trial
Official title:
Inflammatory Back Pain and Gluten Free Diet
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Internal Medicine, University Hospital of Palermo | Palermo | |
Italy | Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca | Sciacca | Agrigento |
Lead Sponsor | Collaborator |
---|---|
University of Palermo |
Italy,
Calin A, Porta J, Fries JF, Schurman DJ. Clinical history as a screening test for ankylosing spondylitis. JAMA. 1977 Jun 13;237(24):2613-4. — View Citation
Carroccio A, Brusca I, Mansueto P, D'alcamo A, Barrale M, Soresi M, Seidita A, La Chiusa SM, Iacono G, Sprini D. A comparison between two different in vitro basophil activation tests for gluten- and cow's milk protein sensitivity in irritable bowel syndro — View Citation
Carroccio A, D'Alcamo A, Mansueto P. Nonceliac wheat sensitivity in the context of multiple food hypersensitivity: new data from confocal endomicroscopy. Gastroenterology. 2015 Mar;148(3):666-7. doi: 10.1053/j.gastro.2014.11.047. Epub 2015 Jan 24. No abst — View Citation
Carroccio A, Mansueto P, D'Alcamo A, Iacono G. Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review. Am J Gastroenterol. 2013 Dec;108(12):1845-52; quiz 1853. doi: 10.1038/ajg.2013.353. Epub 2013 Nov 5. — View Citation
Carroccio A, Mansueto P, Iacono G, Soresi M, D'Alcamo A, Cavataio F, Brusca I, Florena AM, Ambrosiano G, Seidita A, Pirrone G, Rini GB. Non-celiac wheat sensitivity diagnosed by double-blind placebo-controlled challenge: exploring a new clinical entity. A — View Citation
Carroccio A, Rini G, Mansueto P. Non-celiac wheat sensitivity is a more appropriate label than non-celiac gluten sensitivity. Gastroenterology. 2014 Jan;146(1):320-1. doi: 10.1053/j.gastro.2013.08.061. Epub 2013 Nov 22. No abstract available. — View Citation
Carroccio A, Soresi M, D'Alcamo A, Sciume C, Iacono G, Geraci G, Brusca I, Seidita A, Adragna F, Carta M, Mansueto P. Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study. — View Citation
Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct — View Citation
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Non-celiac gluten sensitivity: literature review. J Am Coll Nutr. 2014;33(1):39-54. doi: 10.1080/07315724.2014.869996. — View Citation
Mansueto P, Seidita A, D'Alcamo A, Carroccio A. Role of FODMAPs in Patients With Irritable Bowel Syndrome. Nutr Clin Pract. 2015 Oct;30(5):665-82. doi: 10.1177/0884533615569886. Epub 2015 Feb 18. — View Citation
Rudwaleit M, Metter A, Listing J, Sieper J, Braun J. Inflammatory back pain in ankylosing spondylitis: a reassessment of the clinical history for application as classification and diagnostic criteria. Arthritis Rheum. 2006 Feb;54(2):569-78. doi: 10.1002/a — View Citation
Sieper J, van der Heijde D, Landewe R, Brandt J, Burgos-Vagas R, Collantes-Estevez E, Dijkmans B, Dougados M, Khan MA, Leirisalo-Repo M, van der Linden S, Maksymowych WP, Mielants H, Olivieri I, Rudwaleit M. New criteria for inflammatory back pain in pati — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from baseline at 12 months | |
Primary | 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. | Change from baseline at 12 months | |
Secondary | Prevalence of IBP in CD and in NCWS patients. | Prevalence of IBP in CD and in NCWS patients. | up to 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01673633 -
Sacroiliitis in Systemic Sclerosis
|
N/A | |
Completed |
NCT05327140 -
Reliability of IBP Criteria & Activity Scores in Patients With AxSpA
|