Non-Celiac Gluten Sensitivity (NCGS) is a syndrome characterized by intestinal
and extra-intestinal symptoms related to the ingestion of gluten-containing
food, in subjects that are not affected by either celiac disease or wheat
allergy. Given the lack of a NCGS biomarker, there is the need for
standardizing the procedure leading to the diagnosis confirmation. In this
paper we report experts’ recommendations on how the diagnostic protocol should
be performed for the confirmation of NCGS. A full diagnostic procedure should
assess the clinical response to the gluten-free diet (GFD) and measure the
effect of a gluten challenge after a period of treatment with the GFD. The
clinical evaluation is performed using a self-administered instrument
incorporating a modified version of the Gastrointestinal Symptom Rating Scale.
The patient identifies one to three main symptoms that are quantitatively
assessed using a Numerical Rating Scale with a score ranging from 1 to 10. The
double-blind placebo-controlled gluten challenge (8 g/day) includes a one-week
challenge followed by a one-week washout of strict GFD and by the crossover to
the second one-week challenge. The vehicle should contain cooked,
homogeneously distributed gluten. At least a variation of 30% of one to three
main symptoms between the gluten and the placebo challenge should be detected
to discriminate a positive from a negative result. The guidelines provided in
this paper will help the clinician to reach a firm and positive diagnosis of
NCGS and facilitate the comparisons of different studies, if adopted
internationally