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

Not Applicable

Completed

• Conditions: Non Celiac Gluten Sensitivity
• Interventions: Dietary Supplement: Lactose free placebo; Dietary Supplement: High dose Gluten; Dietary Supplement: Low dose Gluten

• Registration Number: NCT02936297
• Lead Sponsor: Thomas Jefferson University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactose free placebo	Lactose free placebo	Lactose free placebo pill
High Dose Gluten (2.0g)	High dose Gluten	High dose gluten pill
Low dose Gluten (0.5g)	Low dose Gluten	Low dose gluten pill

Primary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States