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Inflammatory Back Pain and Gluten Free Diet

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary 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
  2. Notable Start date: Jan 1, 2025 to Jul 1, 2025v16
  3. Minor Site details revised at 1 of 2 sites
    • Publications: details revised at 12 of 12 entries
    v15
  4. Notable Primary 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
  5. Notable Primary 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
  1. Notable Start date: Dec 1, 2022 to Aug 1, 2023
    • Primary completion date: Jun 1, 2023 to Oct 1, 2023
    v12
  2. Notable Primary completion date: Dec 1, 2022 to Jun 1, 2023
    • Start date: Jun 1, 2022 to Dec 1, 2022
    v11
  3. Notable Start date: Jan 1, 2022 to Jun 1, 2022v10
  4. Notable Start date: Jun 1, 2021 to Jan 1, 2022v9
  5. Notable Primary 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
  6. Notable Primary 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
  7. Notable Start 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
  8. Notable Start date: Sep 1, 2018 to Nov 1, 2018v5
  9. Notable Primary 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
  10. Notable Start date: Jan 2018 to Apr 2018v3
  11. Notable Primary 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
  1. Minor Study 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Trial Details
NCT Number NCT03017716
Lead Sponsor University of Palermo
Conditions
(from sponsor)
Inflammatory Back Pain
Related terms Celiac Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov