Experimental Study to Determine the Effects of Human Refluxate (Biliary, Gastric, Duodenogastric) on Macrophage Phenotype and Its Correlation With Different Forms of GERD: Motility Talent Group Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 4
- 主要终点
- The Number of Reflux in GERD Patients
研究概览
简要总结
This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.
详细描述
Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).
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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical (patients) part
- •Signed informed consent
- •Gender: Male or Female
- •Age: 18-65 years of age
- •Clinically and/or endoscopically confirmed diagnosis of GERD
排除标准
- •Clinical: (patient)
- •Current treatment with proton pump inhibitors and/or histamine-2 receptor antagonists. These treatments should have been stopped at least 1 week prior to study inclusion.
- •Female patients who are pregnant, planning to become pregnant or lactating
- •Any acute diseases or conditions, exacerbations of concomitant chronic diseases (including but not limited to inflammatory bowel disease (IBD), ulcer disease etc.) at study start/inclusion and/or which are not resolved 14 days prior to study-enrolment.
- •Participation in a clinical trial in the past 3 months
- •Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
结局指标
主要结局
The Number of Reflux in GERD Patients
时间窗: Day 4
We analyzed the number of acid and weakly acid reflux episodes in GERD patients
次要结局
未报告次要终点
研究者
Ivashkin Vladimir Trofimovich
MD, PhD, professor, head of department of propedeutics of internal diseases, director of clinic of propedeutics of internal diseases
I.M. Sechenov First Moscow State Medical University