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Inflammatory Back Pain and Gluten Free Diet

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ClinicalTrials.gov Identifier: NCT03017716
Recruitment Status : Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Back Pain Other: Gluten free diet Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inflammatory Back Pain and Gluten Free Diet
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
No Intervention: IBP patients on standard therapy
IBP patients on standard therapy.
Active Comparator: IBP patients on standard therapy and GFD
IBP patients on standard therapy and GFD
Other: 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.




Primary Outcome Measures :
  1. Musculoskeletal (back pain) evaluation at baseline and after GFD [ Time Frame: Change from baseline at 12 months ]
    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.

  2. Changes in cytokines production from peripheral blood mononuclear (PBMC) at baseline and after GFD [ Time Frame: Change from baseline at 12 months ]
    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.


Secondary Outcome Measures :
  1. Prevalence of IBP in CD and in NCWS patients. [ Time Frame: up to 12 months ]
    Prevalence of IBP in CD and in NCWS patients.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017716


Contacts
Contact: Antonio Carroccio, PhD +390916552884 acarroccio@hotmail.com
Contact: Pasquale Mansueto, MD +390916552884 pasquale.mansueto@unipa.it

Locations
Italy
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca Recruiting
Sciacca, Agrigento, Italy, 92019
Contact: Antonio Carroccio, MD, PhD    +390916554347    acarroccio@hotmail.com   
Department of Internal Medicine, University Hospital of Palermo Recruiting
Palermo, Italy, 90129
Contact: Pasquale Mansueto, MD    +390916554347    pasquale.mansueto@unipa.it   
Sponsors and Collaborators
University of Palermo
Investigators
Study Director: Antonio Carroccio, PhD University of Palermo

Publications of Results:

Responsible Party: Pasquale Mansueto, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT03017716     History of Changes
Other Study ID Numbers: ACPM14
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pasquale Mansueto, University of Palermo:
Inflammatory back pain
gluten-free diet
celiac disease
non-celiac wheat sensitivity

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms