Pancreatitis - Microbiome As Predictor of Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 424
- 试验地点
- 2
- 主要终点
- Revised Atlanta classification I-III
研究概览
简要总结
This study is a multicentric prospective study initiated and coordinated from the University Medical Centre Goettingen. The study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.
详细描述
This prospective translational study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis. From each patient one buccal and rectal swab is collected within 72 h after hospital admission. Microbial composition will be determined by 16S and metagenomics Oxford Nanopore Sequencing (ONT) and correlated with the revised Atlanta classification as the primary endpoint. Secondary endpoints are the correlation of microbiome signatures with the length of hospital stay, numbers of interventions and mortality. To this end, alpha and beta diversity of microbiota are determined and compared between mild, moderately severe and severe acute pancreatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pancreatitis (2 out of 3 following diagnostic criteria: lipase >3x of upper limit, abdominal pain, and imaging modalities (computed tomography, magnetic resonance imaging or ultrasound).
- •< 72 hours after hospital admission.
排除标准
- •Pregnant women Patients < 18 years; Patients who are incapable of giving consent
结局指标
主要结局
Revised Atlanta classification I-III
时间窗: up to 8 weeks
Microbial composition (alpha and beta-diversity) will be correlated with the revised Atlanta classification.
次要结局
- Length of hospital stay(up to 12 months)
- Mortality(up to 12 months)
- Numbers of interventions (surgical and endoscopical)(up to 12 months)
研究者
Albrecht Neesse
Prof. Dr. Dr.
University Medical Center Goettingen