Intestinal Permeability and Gastroparesis

Study Overview
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Brief Summary
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The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.

Official Title
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Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis

Conditions
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Gastroparesis, Healthy

Intervention / Treatment
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* Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (18-75 years old). Men and women. Patients with gastroparesis. Exclusion Criteria: Patients will be excluded from the study if symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), GERD, esophagitis, eosinophilic esophagitis or H. pylori. Patients with uncontrolled diabetes mellitus (hemoglobin A1C > 10). Patients with prior surgery to the esophagus, stomach or duodenum. Patients taking opioids, steroids, anti-histamines, immunosuppressive agents, NSAIDs, or mast cell stabilizing agents within the prior 3 months. Patients currently prescribed aspirin or aspirin regimens for other clinical reasons. Patients with known allergies to lactulose: mannitol will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastroparesis patients<br> | Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy<br>* Tests to assess intestinal permeability<br>|
| Active Comparator: Healthy volunteers<br> | Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy<br>* Tests to assess intestinal permeability<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy. |  | through study completion, approximately 3-4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess small intestinal permeability using the lactulose:mannitol urinary excretion test. |  | through study completion, approximately 3-4 days | 
| Measure serum levels of immune markers (e.g., IL-1,4,6,10,12,13,18; zonulin, CRP, TNF-alpha, tryptase,) in GP patients and compare to healthy controls. |  | One time measurement | 
| Quantitate different duodenal cell types (e.g., mast cells (CK117), eosinophils, enterochromaffin, intraepithelial lymphocytes (IELs) and CCK-containing cells) in patients with GP using biopsies from both the D1 and D2 duodenal segments. |  | through study completion, approximately 3-4 days | 
| Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes. |  | through study completion, approximately 3-4 days |