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

Non Celiac Gluten Sensitivity Clinical Trial

— NCGS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936297
• Other study ID #: IRB#16D.244
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: March 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Non Celiac Gluten Sensitivity

Intervention

Dietary Supplement:
• High dose Gluten

• Low dose Gluten

• Lactose free placebo

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)		12 weeks
Primary	NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD		12 weeks
Primary	Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.		12 weeks
Primary	Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD		12 weeks
Primary	Patient Estimation of Gluten Intake captured via (PEGI) questionnaire		12 weeks