NCT04894656撤回不适用
Assessing Intestinal Barrier Function and Permeability in Patients With Gastroparesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
研究概览
简要总结
The purpose of this study is to investigate potential mechanisms that could lead to the development of a condition known as gastroparesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (18-75 years old).
- •Men and women.
- •Patients with gastroparesis.
排除标准
- •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.
结局指标
主要结局
Assess duodenal epithelial tight junction structure in GP patients using confocal laser endomicroscopy.
时间窗: through study completion, approximately 3-4 days
次要结局
- Assess small intestinal permeability using the lactulose:mannitol urinary excretion test.(through study completion, approximately 3-4 days)
- 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)
- 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)
- Assess the relationship of GP symptoms to intestinal permeability, using validated questionnaires, and to histopathological changes.(through study completion, approximately 3-4 days)
研究者
David J. Cangemi
Principal Investigator
Mayo Clinic
相似试验
尚未招募
不适用
Clinical Study of Intestinal Barrier Dysfunction After Gastrointestinal SurgeryIntestinal Barrier DysfunctionNCT06596070The Second Affiliated Hospital of Kunming Medical University180
已完成
不适用
Biomarkers for Intestinal Permeability in Patients With ConstipationIrritable Bowel SyndromeIntestinal DiseasesConstipationNCT02246647Mayo Clinic39
已完成
不适用
Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?Irritable Bowel SyndromeNCT02877654University Hospital, Rouen67
已完成
不适用
Study of Intestinal Permeability in Patients With Anorexia NervosaAnorexia NervosaNCT02170467University Hospital, Rouen51
已完成
2 期
Intestinal PermeabilityIntestinal PermeabilityNCT01049386TNO16