Intestinal Permeability and Gastroparesis

Not Applicable

Withdrawn

• Conditions: Gastroparesis; Healthy
• Interventions: Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy

• Registration Number: NCT04894656
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-20
• Study Start: 2022-04-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients (18-75 years old).
• Men and women.
• Patients with gastroparesis.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy	-
Gastroparesis patients	Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy	-

Primary Outcome Measures

Name	Time	Method
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.	through study completion, approximately 3-4 days

Secondary Outcome Measures

Name	Time	Method
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.	through study completion, approximately 3-4 days
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
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
Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.	through study completion, approximately 3-4 days