Analysis of Biliary Microbiota in Hepatobiliopancreatic Diseases Compared to Healthy People [MICROBILIO]
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Composition of the biliary microbiota
研究概览
简要总结
The performance of the microbiota is observed in all clinical and pathological stages of carcinogenesis, since its development, diagnosis and treatment, including prognosis and survival. However, it was found that there is a scarcity of studies on biliary microbiota and its relationship with hepatobiliopancreatic diseases. Therefore, further investigation is necessary, since reaching the biliary microbiota may suggest ways for studies of biomarkers, diagnoses, tests and therapies in hepatobiliopancreatic diseases. For this, bile samples will be collected in cases and controls patients to characterize the microbiota and its variations according to the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Endoscopic retrograde cholangiopancreatography (ERCP) candidates (case group)
- •Patients over 18 years old complete
- •Patients previously scheduled for ERCP
- •Cannulation of the bile duct, via the transpapillary route, with the aid of a papillotome with an end kept sterile until contact with the papilla
- •Liver transplant living-donor (control group)
- •Patients over 18 years old up to 55 years
- •Previously selected patients with scheduled surgery
- •BMI: 18 kg / m² to 28 kg / m²
- •Blood typing identical to the recipient
- •Absence of significant medical, psychiatric problems or previous abdominal surgery
- •Normal laboratory tests: liver function tests, blood count, coagulogram, pregnancy test and serology for hepatitis B, C and HIV
- •Normal imaging exams: CT of the abdomen and pelvis with liver volume (remaining volume - 30-40% of the total liver volume), MRI with cholangioresonance
排除标准
- •ERCP candidates (case group)
- •Use of antibiotics during ERCP or in the last 2 months prior to the procedure
- •Emergency ERCP
- •Pregnancy
- •Uncorrected coagulopathy
- •Liver transplant living-donor (control group)
- •Use of antibiotics in the last 2 months prior to the procedure
- •Pregnancy
- •Uncorrected coagulopathy
结局指标
主要结局
Composition of the biliary microbiota
时间窗: 2 years
In this study, the investigator's objective will be to characterize the specific composition of the biliary microbiota in patients with hepatobiliopancreatic diseases in comparison with healthy people using 16S ribosomal RNA (rRNA) pyrosequencing methods.
次要结局
未报告次要终点
研究者
Alberto Meyer, MD PhD FACS
Principal Investigator
University of Sao Paulo