[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100287135":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":64,"collaborators":12,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":12,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":12,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Palermo","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"IBP patients on standard therapy","NO_INTERVENTION","IBP patients on standard therapy.",null,{"label":14,"type":15,"description":14,"interventionNames":16},"IBP patients on standard therapy and GFD","ACTIVE_COMPARATOR",[17],"Other: Gluten free diet",[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":12},"Gluten free diet","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.",[14],[24],{"name":25,"affiliation":5,"role":26},"Antonio Carroccio, PhD","STUDY_DIRECTOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":12,"email":31},"CONTACT","+390916552884","acarroccio@hotmail.com",{"name":33,"role":29,"phone":30,"phoneExt":12,"email":34},"Pasquale Mansueto, MD","pasquale.mansueto@unipa.it",[36,53],{"facility":37,"status":12,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca","Sciacca","Agrigento","92019","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],13.08399,37.50693,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":12,"email":31},"Antonio Carroccio, MD, PhD","+390916554347",{"facility":54,"status":12,"city":55,"state":55,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Department of Internal Medicine, University Hospital of Palermo","Palermo","90129",{"type":44,"coordinates":58},[59,60],13.3636,38.1166,{"lat":60,"lon":59},[63],{"name":33,"role":29,"phone":52,"phoneExt":12,"email":34},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Pasquale Mansueto","MD","100287135","inflammatory-back-pain-and-gluten-free-diet-100287135",false,"NCT03017716","Inflammatory Back Pain and Gluten Free Diet","Inclusion Criteria:\n\nTo diagnose IBP the standard Berlin Criteria will be adopted. IBP is defined by at least 2 positive responses among four items:\n\n* morning stiffness \\>30 min of duration\n* improvement in back pain with exercise but not with rest\n* awakening because of back pain during the second half of the night only\n* alternating buttock pain.\n\nTo diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:\n\n* positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* presence of intestinal villous atrophy.\n\nTo diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:\n\n* negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies\n* absence of intestinal villous atrophy\n* negative IgE-mediated immune-allergy tests to wheat (skin prick tests and\u002For serum specific IgE detection)\n* 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\n* 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.\n\nExclusion Criteria:\n\nExclusion criteria for NCWS diagnosis will be:\n\n* positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi\u002Fcrypts ratio in the duodenal mucosa\n* self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study\n* other previously diagnosed gastrointestinal disorders\n* other previously diagnosed rheumatic diseases\n* nervous system disease and\u002For major psychiatric disorder\n* physical impairment limiting physical activity.","ALL","18 Years","65 Years",{"count":78,"type":79},50,"ESTIMATED","INTERVENTIONAL",[82],"NA","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\u002For 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.",[85],"Inflammatory Back Pain",[87,88,89,90],"Inflammatory back pain","gluten-free diet","celiac disease","non-celiac wheat sensitivity","NOT_YET_RECRUITING","2026-01-08",{"date":94,"type":95},"2026-01-09","ACTUAL",{"date":97,"type":79},"2026-07-01",{"date":99,"type":79},"2028-01-01",{"name":5,"class":6},2]