Gastroparesis, Healthy
Conditions
Brief summary
The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.
Interventions
DIAGNOSTIC_TESTLabs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
Tests to assess intestinal permeability
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy. | through study completion, approximately 3-4 days |
Secondary
| Measure | 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 |
Outcome results
None listed