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
NCT ID: NCT02936297
Last Updated: 2020-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2016-06-30
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
TRIPLE
Study Groups
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Lactose free placebo
Lactose free placebo pill
Lactose free placebo
Low dose Gluten (0.5g)
Low dose gluten pill
Low dose Gluten
High Dose Gluten (2.0g)
High dose gluten pill
High dose Gluten
Interventions
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High dose Gluten
Low dose Gluten
Lactose free placebo
Eligibility Criteria
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Inclusion Criteria
* Patients willing to maintain gluten free diet for 6 weeks
Exclusion Criteria
* 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
* NCGS
* Celiac disease
* Inflammatory bowel disease
* Irritable bowel syndrome
* Acute gastroenteritis
* Patients who are pregnant
* Type 1 Diabetes Mellitus
18 Years
80 Years
ALL
Yes
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Locations
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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IRB#16D.244
Identifier Type: -
Identifier Source: org_study_id
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