H F Dale1, J G Hatlebakk1,2,3, N Hovdenak1, S O Ystad1,3, G A Lied1,2,3. 1. Centre for Nutrition, Department of Clinical Medicine, University of Bergen, Bergen, Norway. 2. Section of Gastroenterology, Department of Medicine, Haukeland University Hospital, Bergen, Norway. 3. National Centre of Functional Gastrointestinal Disorders, Haukeland University Hospital, Bergen, Norway.
Abstract
BACKGROUND: 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). METHODS: 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. KEY RESULTS: 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). CONCLUSIONS AND INFERENCES: 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.
BACKGROUND: 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). METHODS: 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. KEY RESULTS: 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). CONCLUSIONS AND INFERENCES: 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.
Authors: Imke Reese; Christiane Schäfer; Jörg Kleine-Tebbe; Birgit Ahrens; Oliver Bachmann; Barbara Ballmer-Weber; Kirsten Beyer; Stephan C Bischoff; Katharina Blümchen; Sabine Dölle; Paul Enck; Axel Enninger; Isidor Huttegger; Sonja Lämmel; Lars Lange; Ute Lepp; Vera Mahler; Hubert Mönnikes; Johann Ockenga; Barbara Otto; Sabine Schnadt; Zsolt Szepfalusi; Regina Treudler; Anja Wassmann-Otto; Torsten Zuberbier; Thomas Werfel; Margitta Worm Journal: Allergo J Int Date: 2018-05-28