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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
90
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
Time frame: 12 weeks
NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
Time frame: 12 weeks
Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
Time frame: 12 weeks
Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
Time frame: 12 weeks
Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
Time frame: 12 weeks
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