Non-Celiac Wheat Sensitivity Clinical Trial
Official title:
Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? A Follow-up Study
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.
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.
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