Intestinal Permeability and Gastroparesis

Mayo Clinic

Status: Withdrawn

Conditions: Healthy; Gastroparesis

Treatments: Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04894656

21-000771

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Gastroparesis patients

Experimental group

Treatment:

Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy

Healthy volunteers

Active Comparator group

Treatment:

Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy