The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of diarrhoea
研究概览
简要总结
Primary objective of this study is to measure the change of concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will be taken from the patient. First faecal sample is the first stool after initiation of EN and second sample is taken seven days after the initial sample and the third faecal sample is taken at day 14 after initial sample. Patient will be randomized to receive either of described formula after baseline (first) stool sample is obtained. Patient will be monitored up to 14 days after the initial stool sample is obtained.
详细描述
Written approval of the study has been obtained from the University Malaya Medical Centre (UMMC) Ethics Committee before commencement of this study
Patients will be screened for inclusion and exclusion criteria of the study and consent will be obtained from the patients or their legal representative in view of most critically ill patients are unconscious. Patients or their legal representative will be briefed regarding the objectives and the design of the study.
Critically ill patients recruited for this study will be exclusively on EN as clinically indicated. The volume of formula prescribed is based on each patient's total energy expenditure, which will be calculated by clinical dietitians. Formula will be delivered through a Ryles tube according to dietitians' order.
A faecal sample from the recruited patients will be collected for analysis at baseline, the first stool output after initiation of EN. Once baseline sample is collected, patients will be randomly assigned to receive enteral formula with or without prebiotics. Randomisation will be generated by using the website Randomization.com (http://www.randomization.com). Patients will be monitored for at least 14 days from passage of the first faecal sample after initiation of EN.
A faecal sample will be collected for analysis on days 0, 7, and 14. If there is absence of habitual or meal cues to stool output, samples will be collected and analyzed from each patient during 3 days periods at Day 6-8 for second faecal sample and Day 12-14 for the third faecal sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients receiving exclusive EN , nasogastric, continuous infusion
- •Adult patients , 18 years old and above
- •Critically ill patients
- •Expected to require EN more than five days(Bleichner et al., 1997)
排除标准
- •Patients with gastrointestinal disease (Sokol et al., 2006) or GIT surgery
- •Patients receiving lactulose (Bouhnik et al., 2004)
- •Currently under chemotherapy treatment (Kapkac et al., 2003)
- •Patients who had received prebiotics and probiotics supplements within the previous one month
- •Patients who have diarrhoea, 3 consecutive days (Majid et al, 2013)
结局指标
主要结局
Incidence of diarrhoea
时间窗: up to 14 days post intervention
次要结局
- Changes in faecal microbiota(baseline, 1 week & 2 weeks after baseline sample)
研究者
Mazuin Kamarul Zaman
Mrs
University of Malaya