Send to

Choose Destination
Neurogastroenterol Motil. 2018 Mar 15. doi: 10.1111/nmo.13332. [Epub ahead of print]

The effect of a controlled gluten challenge in a group of patients with suspected non-coeliac gluten sensitivity: A randomized, double-blind placebo-controlled challenge.

Author information

Centre for Nutrition, Department of Clinical Medicine, University of Bergen, Bergen, Norway.
Section of Gastroenterology, Department of Medicine, Haukeland University Hospital, Bergen, Norway.
National Centre of Functional Gastrointestinal Disorders, Haukeland University Hospital, Bergen, Norway.



Non-coeliac gluten-sensitivity (NCGS) has been proposed as a new entity with unknown prevalence and mechanisms, and there is a need for a standardized procedure to confirm the diagnosis. The objective of this study was to characterize the response to an oral gluten-challenge in patients with a symptom-relief when following a gluten free-diet (GFD).


Twenty patients (14F/6M, age range: 21-62 years) with suspected NCGS, without coeliac disease and wheat-allergy, were included while on a gluten-free diet. All patients went through four periods of double-blinded provocation, two with gluten and two with placebo in randomized order. They consumed two muffins a day (11/0 g gluten) for 4 days, followed by a 3-day wash-out. Gastrointestinal symptoms were recorded with questionnaires at baseline and after each provocation. We also investigated whether patients were able to correctly identify periods with gluten-exposure.


Collectively the whole group reported the most severe symptoms after placebo (P = .012). Four out of twenty patients correctly identified the two periods when they received gluten, hence were diagnosed with NCGS. The diagnosed-group tended to show higher symptom scores than the not-diagnosed group both at baseline, after gluten exposure and after placebo, but no clear difference was seen between provocation with gluten and placebo. The not-diagnosed group showed more severe symptoms with placebo than with gluten (P = .029).


The present study showed that the majority of patients with suspected NCGS are not able to identify when challenged with gluten in a double-blind placebo-controlled food challenge, indicating that gluten is not the cause of their symptoms.


FODMAPs; double-blind placebo-controlled food challenge; gluten; non-coeliac gluten sensitivity; non-coeliac wheat sensitivity


Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center