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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non Celiac Gluten Sensitivity

Intervention / Treatment
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* Dietary Supplement: High dose Gluten
* Dietary Supplement: Low dose Gluten
* Dietary Supplement: Lactose free placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactose free placebo<br>Lactose free placebo pill | Dietary Supplement: Lactose free placebo<br> <br> |
| Active Comparator: Low dose Gluten (0.5g)<br>Low dose gluten pill | Dietary Supplement: Low dose Gluten<br> <br> |
| Active Comparator: High Dose Gluten (2.0g)<br>High dose gluten pill | Dietary Supplement: High dose Gluten<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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