Understanding Changes in the Gut Microbiome in Patients With Gallstone Disease and Its Impact on Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Bacterial DNA profile
研究概览
简要总结
The goal of this prospective observational study is to explore the role of the gut microbiome in patients with gallstone disease.
The main question[s] it aims to answer are:
- if there is a relationship between the gut microbiome and the development of complications associated with gallstone disease (such as pancreatitis and acute cholecystitis)
- if there are changes in the gut microbiome following cholecystectomy and the relationship with patient outcomes.
Participants will be asked to provide stool samples at fixed time points (recruitment, pre- and post-cholecystectomy if applicable and at 6 months and 3 years. They will also be asked to provide stool samples if they represent to hospital with complications associated with their gallstone disease.
详细描述
Background:
Gallstone disease affects 10-15% of people in the United Kingdom (UK) and over 65,000 patients undergoing cholecystectomy each year, costing the National Health Service (NHS) over 110 million. There is increasing evidence suggesting differences in the gut microbiome of patients with gallstone disease compared to those without (including reduced diversity, decreased prevalence of beneficial and increased prevalence of pathogenic bacteria) but there are only a handful of small scale studies exploring the development of gallstone disease complications and patient outcomes to date.
Hypothesis and Objectives:
This pilot study aims to understand the profile of the gut microbiome in adult patients diagnosed with gallstone disease and its relationship with patient outcomes including:
Patients who develop complications of gallstone disease(including but not limited to biliary colic, cholangitis, cholecystitis, pancreatitis and gallstone ileus) following diagnosis and Patients who develop post-operative complications including short (hospital stay, wound healing etc) and intermediate (development of post-cholecystectomy diarrhoea) outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •All adults (age >18 years of age) patients diagnosed with gallstone disease following confirmatory imaging at an East Kent University Foundation Trust Hospital. Patients of any gender, ethnicity or socio-economic background are eligible as well as pregnant women. Patients undergoing both open and laparoscopic cholecystectomy will be included.
排除标准
- •Patients less than 18 years of age and patients who do not have capacity to consent to involvement in the study.
结局指标
主要结局
Bacterial DNA profile
时间窗: through study completion, up to 3 years from cholecystectomy
The diversity of species present in the stool of participants
次要结局
未报告次要终点