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

Summary 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