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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose free placebo | Placebo Comparator | Lactose free placebo pill |
|
| Low dose Gluten (0.5g) | Active Comparator | Low dose gluten pill |
|
| High Dose Gluten (2.0g) | Active Comparator | High dose gluten pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Gluten | Dietary Supplement |
| ||
| Low dose Gluten |
| 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 |
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Inclusion criteria include
Exclusion Criteria (NCGS):
Exclusion criteria (healthy controls):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Dietary Supplement |
|
| Lactose free placebo | Dietary Supplement |
|
| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |
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