Intestinal Permeability and Gastroparesis

Mayo Clinic

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Gastroparesis Healthy

Interventions

Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopyDIAGNOSTIC_TEST

Tests to assess intestinal permeability

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.

Time frame: through study completion, approximately 3-4 days

Secondary Outcomes

Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.

Time frame: 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.

Time frame: 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.

Time frame: through study completion, approximately 3-4 days

Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.

Time frame: through study completion, approximately 3-4 days

Data from ClinicalTrials.gov

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