NCT04894656

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

May 11, 2021

Last Update Submit

April 17, 2023

Conditions

GastroparesisHealthy

Outcome Measures

Primary Outcomes (1)

  • Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.

    through study completion, approximately 3-4 days

Secondary Outcomes (4)

  • 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

Study Arms (2)

Gastroparesis patients

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

Healthy volunteers

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

Interventions

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

Tests to assess intestinal permeability

Gastroparesis patientsHealthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18-75 years old).
  • Men and women.
  • Patients with gastroparesis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Gastroparesis

Interventions

UrinalysisGastroscopyBiopsy

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative TechniquesEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresCytodiagnosisCytological TechniquesSpecimen Handling

Study Officials

  • David Cangemi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2021

First Posted

May 20, 2021

Study Start

April 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

April 19, 2023

Record last verified: 2023-04