Non-Celiac Wheat Sensitivity: Permanent or Transient Condition?
Condition: Non-Celiac Wheat Sensitivity
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related
      diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease
      (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive
      and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination
      and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has
      been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components
      other than gluten can cause the symptoms, and therefore the term "non-celiac wheat
      sensitivity" (NCWS) has been proposed instead of NCGS. While it is well known that CD is a
      long-life condition and a strict adherence to the gluten-free diet must be maintained, it is
      unknown whether this is valid for NCWS. On the year 2012, the researchers published a
      retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms
      who had been diagnosed with NCWS using a DBPC challenge during a ten-years period
      (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients
      are still following a wheat-free diet, and B) which percentage was still suffering from NCWS,
      diagnosed by DBPC wheat challenge, in a subgroup of that cohort.
    

Detailed description: 
      Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related
      diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease
      (CD) diagnosis by negative CD-specific serum antibodies and absence of intestinal villi
      atrophy, and excluding IgE-mediated wheat allergy, by negative serum specific IgE and/or skin
      prick test with wheat antigens. Then, in the absence of sensitive and specific diagnostic
      biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of
      wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as
      diagnostic hallmark. Obviously, this a cumbersome and time-consuming procedure which has been
      used in few studies.

      Despite an increasing percentage of the general population define themselves as
      "gluten-sensitive", and by the year 2017 the market of the gluten-free products will be worth
      6.6 billion of dollars, doubts persist about many aspects of NCGS. Some studies seem to
      suggest that wheat components other than gluten can cause the symptoms, and therefore the
      term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. Furthermore,
      while it is well known that CD is a long-life condition and a strict adherence to the
      gluten-free diet must be maintained, it is unknown whether this is valid for NCWS.

      On the year 2012, the researchers published a retrospective study, including 276 patients
      with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a
      DBPC challenge during a ten-years period (2001-2011).

      The present prospective study aimed to evaluate the persistence of the NCWS condition in that
      cohort and, consequently, the researchers estimated : A) how many of these patients are still
      following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed
      by DBPC wheat challenge, in a subgroup of that cohort.
    

Intervention name(s): Patients recruitment
Intervention type(s): Other
Intervention description(s): Between July and November 2016, the patients included in the previous retrospective study were contacted by phone, mail and e-mail and invited to come back to the respective clinics where they had been initially diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (province of Agrigento).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients included in the previous retrospective study were contacted by phone, mail and
        e-mail and invited to come back to the respective clinics where they had been initially
        diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital
        of Palermo and the Department of Internal Medicine of the Hospital of Sciacca.