Non Celiac Gluten Sensitivity, a Double Blind Placebo Controlled Food Challenge With Cross-over in Healthy Danish Adolescents

Non Gluten Sensitivity, a double blind placebo controlled food challenge with cross-over in healthy Danish Adolescents

Caecilie Crawley, Nadia Savino, Cecilie Halby, Stine Dydensborg Sander, Anne-Marie Nybo Andersen, Joseph Murray, Robin Christensen, Steffen Husby

INTRODUCTION Non-celiac gluten sensitivity (NCGS) is a newly described disease entity, where the individual shows signs of sensitivity to gluten, but with no evidence of IgE-mediated wheat allergy or CD (1). The extent and severity of NCGS is so far an enigma (2), but symptoms of NCGS may be commonly occurring, with a reported prevalence of up to 6% of the adult population (3). So far, only ten studies with a double-blind placebo-controlled food challenge have been performed showing divergent study outcomes due to different study designs and methods and a significant nocebo/placebo effect. In general, the studies are characterized by patient recruitment from a gastroenterological clinic limited to adults (4). Our study stands out in this respect, as we will investigate an unselected group of patients as adolescents (not recruited from an outpatient clinic), because patients with NCGS often report that their symptoms started at that time.

Several researchers have concluded that patients with NCGS may not react to gluten but instead to dietary carbohydrates, so-called FODMAPS or amylase trypsin inhibitors (5). A study with Double Blind Placebo Controlled Food Challenges by Lundin et al. (6) has been published but with inconclusive results. Given this background, contrary to CD, factors involved in the etiology of NCGS are still unknown. In a search for biomarkers and perhaps even contributing factors for NCGS, a microbial signature of the gut would be a good candidate.

METHODS Study Design In a population based on healthy adolescents we conducted a double blind placebo controlled food challenge (DBPCFC) with cross-over to identify patients with NCGS as recommended by the Salerno criteria(1). It will take place at Hans Christian Andersen Childrens Hospital at Odense University Hospital, Denmark in November 2020. It was approved by The Regional Committees on Health Research Ethics for Southern Denmark (project no S-20160061) and the Danish Protection Agency (2008-58-0018).