Masked bolus gluten challenge low in FODMAPs implicates nausea and vomiting as key symptoms associated with immune activation in treated coeliac disease

Abstract

Background: In patients with coeliac disease, FODMAPs in gluten-containing foods, and participant anticipation of a harmful (‘nocebo’) effect, may contribute to acute symptoms after gluten challenge. Aim: To establish acute gluten-specific symptoms linked to immune activation in coeliac disease. Methods: We included 36 coeliac disease patients on a gluten-free diet receiving placebo in the RESET CeD trial. Double-blind, bolus vital wheat gluten (~6-g gluten protein) and sham challenges low in FODMAPs were consumed 2 weeks apart. Assessments included daily Coeliac Disease Patient Reported Outcome (CeD PRO) symptom scores (0-10), adverse events and serum interleukin-2 (baseline and 4 hours). Results: Median CeD PRO score for nausea increased most (sham: 0 vs gluten: 5.5; P