Intestinal Permeability and Gastroparesis

Sponsor

Mayo Clinic (Other)

Overall Status

Suspended

CT.gov ID

NCT04894656

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastroparesis Healthy	Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gastroparesis patients	Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy Tests to assess intestinal permeability
Active Comparator: Healthy volunteers	Diagnostic Test: Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy Tests to assess intestinal permeability

Arm

Intervention/Treatment

Experimental: Gastroparesis patients

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

Tests to assess intestinal permeability

Active Comparator: Healthy volunteers

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

Tests to assess intestinal permeability

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: David Cangemi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

David J. Cangemi, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04894656

Other Study ID Numbers:

21-000771

First Posted:

May 20, 2021

Last Update Posted:

Apr 8, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroparesis

Study Results

No Results Posted as of Apr 8, 2022