Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- alteration of bacterial microbiome diversity and evenness following enteral feeding in alcoholic hepatitis
研究概览
简要总结
Drinking large amount of alcohol can cause damage to the liver. If the liver is severely injured by alcohol it can become very inflamed and this condition is called alcoholic hepatitis. Alcoholic hepatitis can be life threatening. There is no cure for alcoholic hepatitis. It is known that stop drinking and have good nutrition can help the liver to recover.
Infections are very common for people who suffer from alcoholic hepatitis. Sometimes these infection can be very severe. It is not always possible to find out where the infection is coming from. But the bacteria living in the bowel may move to other organs causing these infections and an illness like alcoholic hepatitis can cause "bad bacteria" to take over from "good bacteria" in the gut.
This study wants to understand the changes in the bacteria in the bowel of people who have an acute inflammation of the liver cause by alcohol (alcoholic hepatitis).
The investigators will take stool samples from patients admitted in the hospital with alcoholic hepatitis. The investigators will run tests on the stools that can find out which bacteria live in the bowel. Its is expected to find these bacteria to be different from the ones living in the bowel of healthy people. The investigators are interested to see if these bacteria change once the patients are given good nutrition using a small tube from the nose to the stomach. This type of nutrition is used routinely to help improve the liver in severe alcoholic hepatitis. The investigators will take some more stool sample from these patients after the nutrition through the tube has started to check how the bacteria change with nutrition.
Better tools to check the bacteria in the bowel are now available so this can help the investigators to understand better if changing bacteria in the bowel can help recovery in alcoholic hepatitis.
详细描述
Subjects admitted to hospital with a diagnosis of alcoholic hepatitis and who are planned to receive nasogastric feeding for at least 7 days will be eligible for the study.
A stool sample will be collected prior to commence enteral nutrition via nasogastric tube and analysed. Subsequently further stool samples will be collected and analysed at day 3 and day 7 after commencing nasogastric feeding.
DNA will be extracted from each of the samples, and bacterial 16S rRNA genes will be PCR amplified and sent for sequencing at the CGEBM using an Illumina MiSeq machine. This will generate at least 2 million paired end reads (2 x 300 bp), which will be assembled and analysed using the Mothur software platform.The investigators will also analyse the short chain fatty acids profiles within the stool samples using gas chromatography. Shannon Diversity Index will be used to assess the bacterial diversity and Pielou's index will be used to assess species evenness at each time point. Comparison between time points will be performed. Microbiota composition at the different time points will be assessed using Mothur software to detect if there are systematic changes to specific members of the gut microbiota during enteral feeding. Prevalence by different molecular methodologies will be assessed and the results from study patients will be compared with their baseline samples by Fisher's exact test.
Missing data will be handled using a missing indicator.
Subjects will be approached by the team in charge of the clinical care and option to enter the study will be offered. Information leaflet will be provided to the subject 24h before consenting and possibility to discuss with trial team.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults patients: age 16 and above
- •Diagnosis of alcoholic hepatitis confirmed by treating hepatologists and defined as:
- •Bilirubin >80 umol/l
- •Documented history of continuing alcohol harmful use
- •ALT< 500 umol/L
- •Clinical decision to start NG feeding and prospect to continue NG feeding >3 days
排除标准
- •Hepatocellular carcinoma
- •Pregnancy and breastfeeding
- •Inability to provide informed consent
- •Any reasons in the opinion of the investigator which can compromise participation in the trial or affect patient health
结局指标
主要结局
alteration of bacterial microbiome diversity and evenness following enteral feeding in alcoholic hepatitis
时间窗: 7 days
To understand how the gut microbiome changes in patients with AH following enteral feeding.
次要结局
未报告次要终点