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Study withdrawn due to funding.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastroparesis patients | Experimental |
| |
| Healthy volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy | Diagnostic Test | Tests to assess intestinal permeability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy. | through study completion, approximately 3-4 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cangemi, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D016482 | Urinalysis |
| D005773 | Gastroscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003950 | Diagnostic Techniques, Urological |
| D008919 | Investigative Techniques |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D013048 | Specimen Handling |