Intestinal Permeability and Gastroparesis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-000771
NCT ID: NCT04894656
About this study
The purpose of this study is to investigate, using several novel techniques, potential pathophysiologic abnormalities that could lead to the development of symptoms of gastroparesis (GP). The global hypothesis is that patients with GP will be more likely than controls to have abnormalities in duodenal intestinal permeability.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator David Cangemi, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available