Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study

Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study

Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.

Inclusion criteria include

• Patients > 18 years of age
• Patients willing to maintain gluten free diet for 6 weeks

Exclusion Criteria (NCGS):

• Patients < 18 years of age
• Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
• Patients with a diagnosis of inflammatory bowel disease
• Patients with a diagnosis of acute gastroenteritis
• Patients who are pregnant
• Type 1 Diabetes Mellitus

Exclusion criteria (healthy controls):

• NCGS
• Celiac disease
• Inflammatory bowel disease
• Irritable bowel syndrome
• Acute gastroenteritis
• Patients who are pregnant
• Type 1 Diabetes Mellitus