BActeriophages To Treat Liver Disease Eliminating Harmful Bacteria (BATTLE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Survival in patients with and without cytolysin producing E. faecalis in fecal samples
研究概览
简要总结
Alcoholic hepatitis is a disease with a high mortality rate with few treatment options improving survival. Recently certain bacterial strains has been correlated to survival in patients with alcoholic hepatitis.
In the BATTLE-trial the investigators will investigate if certain bacteria are correlated to decreased chance of survival in patients with alcoholic hepatitis.
详细描述
Patients with alcoholic hepatitis who are admitted to Copenhagen University Hospital Hvidovre and Herlev will be invited to participate.
Blood and fecal samples following hospital admission will be collected. Through one-year follow-up correlation of certain bacteria in fecal samples with survival will be investigated.
In particular whether patients with cytolysin producing E. faecalis has a decreased chance of survival compared to patients without this bacteria.
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
- •Bilirubin > 50 micromol/L
- •History of large alcoholic consumption in period prior to hospital admission (in the last six months)
- •No bile-duct obstruction (investigated through US, CT og MRI)
排除标准
- •Hepatocellulary carcinoma
- •Viral hepatitis
- •Autoimmune hepatitis
- •Portal vein thrombosis
- •Pregnancy
- •Expected survival for less than one year caused by other diseases (based on decision from project responsible doctors
结局指标
主要结局
Survival in patients with and without cytolysin producing E. faecalis in fecal samples
时间窗: 6 months
Patient alive/not alive - Cytolysin producing E. faecalis in fecal samples from hospital admission (yes/no)
次要结局
- Survival in patients with and without cytolysin producing E. faecalis in fecal samples(90 days)
研究者
Frederik Cold
Principal Investigator, MD, Ph.d., Specialist Registrar in Medical Gastroenterology
Copenhagen University Hospital, Hvidovre