Intestinal Permeability and Gastroparesis

Healthy Clinical Trial

Official title:

Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04894656
• Other study ID #: 21-000771
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: July 2023

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis
• Healthy

Intervention

Diagnostic Test:
• Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
Tests to assess intestinal permeability

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.		through study completion, approximately 3-4 days
Secondary	Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.		through study completion, approximately 3-4 days
Secondary	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
Secondary	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
Secondary	Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.		through study completion, approximately 3-4 days

External Links

•   Mayo Clinic Clinical Trials