Osteoporosis In Non-Celiac Wheat Sensitivity Patients
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Osteoporosis; Hypersensitivity
Study type: Observational

Summary: 
      Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the
      spectrum of gluten-related disorders. No data are available on the prevalence of low bone
      mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS
      patients and search for correlations with other clinical characteristics.

      This prospective observation study will include 90 NCWS patients with irritable bowel
      syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at
      the Internal Medicine and at the Gastroenterology Units of the University of Palermo.
      Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS
      diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA),
      duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation
      and assessment for daily calcium intake.
    

Detailed description: 
      Celiac disease (CD) has been reported to increase the risk of osteoporosis, with a resulting
      augmented risk of fractures. More 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). In a previous paper the
      investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known
      what component of wheat causes the symptoms in NCGS patients, and the investigators also
      showed that these patients had a high frequency of coexistent multiple food hypersensitivity.
      That previous study also showed a percentage of NCWS patients had weight loss and anemia:
      whether these depended on the intestinal malabsorption or not remains unclear. As yet no data
      are available on the presence and prevalence of low bone mass density (BMD) in NCWS patients.
      The aims of the present study is: 1) to investigate the prevalence of low BMD in NCWS patient
      and 2) to search for a possible correlation between BMD and other clinical characteristics,
      in particular the body mass index (BMI), of NCWS patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include consecutive adult patients with irritable bowel syndrome (IBS)-like
        clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS,
        referred at the Internal Medicine and at the Gastroenterology Units of the University
        Hospital of Palermo, between may 2015 and may 2017.
      
Biospecimen description: 
      Biopsy specimens will be obtained from the bulb and the second duodenal portion
    
Keywords: Non-celiac wheat sensitivity; Multiple food allergy; Body mass index; Osteoporosis