Symptoms of Gluten Ingestion in Patients With Non-Celiac Gluten Sensitivity: A Placebo-Controlled Study Fellows-in-Training Award (Small Intestine Category): 1146

Introduction: Non-celiac gluten sensitivity (NCGS) is defined as the presence of symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. Some evidence has shown that patients with suspected NCGS have significant increase in symptoms after exposure to <5 g of gluten, whereas other studies have not shown this relationship. The measurement of gluten immunogenic peptides (GIP) in stool is a novel method to monitor GFD compliance. Stool GIP were detected in healthy individuals after gluten-containing diet, with a similar test developed for GIP in urine. No studies have investigated the use of these tests in patients with NCGS. Methods: This is a single-center prospective, randomized, double-blinded, cross-over trial to evaluate symptoms in patients with NCGS. 26 patients with NCGS and 39 healthy controls were placed on a strict GFD for the entire trial after receiving education from the Jefferson Celiac Center. Participants had a 7 day run-in period with a placebo to establish a symptom baseline prior to receiving gluten. During the study the patient received 0.5 g to 2.0 g of gluten daily for 7 days each. The remaining weeks they received placebo for a total 4-week study period. NCGS symptoms were evaluated weekly using the Celiac Symptom Index (CSI). Also, urine and stool samples were collected weekly and measured for the detection of GIP. Results: NCGS patients were less likely to have stool GIP compared to healthy patients (OR = 0.251, p < 0.001), with an increase in likelihood when receiving gluten in both groups (OR = 4.815, p < 0.001). NCGS patients were less likely to have urine GIP compared to healthy patients (OR = 0.230, p <0.001). In terms of CSI scores, there was no difference in symptom severity within the NCGS group whether receiving placebo or gluten (32.69 vs. 31.54, p=0.64). There was no difference in symptom severity within the healthy group whether receiving placebo or gluten (23.87 vs. 23.59, p=0.83). NCGS patients had a significantly higher CSI score at baseline (32.69 vs. 23.87, p<0.001), and when receiving gluten (31.54 vs. 23.59, p<0.001) when compared with healthy controls. Conclusion: NCGS patients were more adherent to the GFD based on stool and urine GIP results. NCGS patients had increased symptom severity both at baseline and while receiving gluten compared with healthy controls. There was no worsening of symptoms in either group after ingestion of gluten, based on CSI scores.