Intestinal Permeability and Gastroparesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Gastroparesis Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Gastroparesis patients

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

Tests to assess intestinal permeability

Healthy volunteers

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIAGNOSTIC_TEST

Tests to assess intestinal permeability

Interventions

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

Tests to assess intestinal permeability

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes