NCT02936297

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Non Celiac Gluten Sensitivity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High dose Gluten
DIETARY_SUPPLEMENT	Low dose Gluten
DIETARY_SUPPLEMENT	Lactose free placebo

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-10-18
• Last updated: 2020-03-11

Locations

1 site across 1 country: United States