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NotablePrimary completion date: Oct 1, 2025 to Jan 1, 2027
Start date: Jul 1, 2025 to Jul 1, 2026
Study completion date: Dec 1, 2026 to Jan 1, 2028
Publications: details revised at 12 of 12 entries
v17
NotableStart date: Jan 1, 2025 to Jul 1, 2025v16
MinorSite details revised at 1 of 2 sites
Publications: details revised at 12 of 12 entries
v15
NotablePrimary completion date: Oct 1, 2024 to Oct 1, 2025
Start date: Jan 1, 2024 to Jan 1, 2025
Study completion date: Dec 1, 2024 to Dec 1, 2026
v14
NotablePrimary completion date: Oct 1, 2023 to Oct 1, 2024
Start date: Aug 1, 2023 to Jan 1, 2024
Study completion date: Dec 1, 2023 to Dec 1, 2024
v13
Show 11 earlier versionsHide 11 earlier versions
NotableStart date: Dec 1, 2022 to Aug 1, 2023
Primary completion date: Jun 1, 2023 to Oct 1, 2023
v12
NotablePrimary completion date: Dec 1, 2022 to Jun 1, 2023
Start date: Jun 1, 2022 to Dec 1, 2022
v11
NotableStart date: Jan 1, 2022 to Jun 1, 2022v10
NotableStart date: Jun 1, 2021 to Jan 1, 2022v9
NotablePrimary completion date: Dec 1, 2020 to Dec 1, 2022
Start date: Jun 1, 2020 to Jun 1, 2021
Study completion date: Dec 1, 2021 to Dec 1, 2023
v8
NotablePrimary completion date: Dec 1, 2019 to Dec 1, 2020
Start date: Jun 1, 2019 to Jun 1, 2020
Study completion date: Dec 1, 2020 to Dec 1, 2021
v7
NotableStart date: Nov 1, 2018 to Jun 1, 2019
Primary completion date: Sep 1, 2019 to Dec 1, 2019
Study completion date: Sep 1, 2020 to Dec 1, 2020
v6
NotableStart date: Sep 1, 2018 to Nov 1, 2018v5
NotablePrimary completion date: Jun 2018 to Sep 1, 2019
Start date: Apr 2018 to Sep 1, 2018
Study completion date: Jan 2019 to Sep 1, 2020
v4
NotableStart date: Jan 2018 to Apr 2018v3
NotablePrimary completion date: Jul 2017 to Jun 2018
Start date: Jan 2017 to Jan 2018
Study completion date: Jan 2018 to Jan 2019
Site details revised at 2 of 2 sites
v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.