Back to resultsIntestinal Permeability and Gastroparesis
Primary Purpose
Gastroparesis, Healthy
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroparesis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gastroparesis patients
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
Secondary Outcome Measures
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
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.
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.
Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04894656
Brief Title
Intestinal Permeability and Gastroparesis
Official Title
Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn due to funding.
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Healthy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastroparesis patients
Arm Type
Experimental
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy
Intervention Description
Tests to assess intestinal permeability
Primary Outcome Measure Information:
Title
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
Time Frame
through study completion, approximately 3-4 days
Secondary Outcome Measure Information:
Title
Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.
Time Frame
through study completion, approximately 3-4 days
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Cangemi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Intestinal Permeability and Gastroparesis
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