Intestinal Permeability and Gastroparesis

April 17, 2023 updated by: David J. Cangemi, Mayo Clinic

Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
Time Frame: through study completion, approximately 3-4 days
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
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
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
through study completion, approximately 3-4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-000771

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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