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临床试验/NCT01792401
NCT01792401已完成2 期

Probiotics in Enteral Feeding in Critically Ill Patients

University of Malaya1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
49
试验地点
1
主要终点
Improve the time to return of gut function in patient on enteral feeding in intensive care unit

研究概览

简要总结

The purpose of this study is to investigate the effect of probiotics in enteral nutrition on improving gut function, inflammatory markers and clinical outcomes in critically ill patients admitted to the intensive care unit.

详细描述

Gut failure in critically ill patients is common. Enteral feeding is one of the preferred routes for nutrition support to maintain gut function. However, enteral nutrition is not without complications such as alterations in gut transit time and gut eco-culture. Enteral nutrition supplemented with a probiotic offers a possible solution to modulating this ecosystem. Objectives: The primary aim of this study was to investigate the effect of probiotics in enteral feeding on improving the gut function, inflammatory markers and clinical outcomes in critically ill patients. Subjects and Methods: Forty-nine patients that were admitted to the intensive care unit in University Malaya Medical Center requiring enteral feeding were randomized to receive either probiotics or a placebo. Patients remained in the intensive care unit for more than 7 days and were examined prior to the start of enteral feeding and on day 8. Return of gut function was assessed by the time needed to achieve caloric requirement. Inflammatory markers including the White Cell Count and C-reactive protein levels were tested on day 1 and day 8. Clinical outcome was assessed by number of days of ventilation and total days in intensive care unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to intensive care unit
  • Expected stay of more than 48 hours
  • On enteral feeding
  • Consent obtained from patient/relative

排除标准

  • Patients on immuno-suppressive drugs
  • Patients with hematological diseases
  • Pregnant females
  • Do not consent

研究组 & 干预措施

Placebo

Placebo Comparator

Patients on enteral feeding in intensive care units are administered a placebo

干预措施: Placebo (Drug)

Probiotics

Active Comparator

Patients on enteral feeding in intensive care unit are given a probiotic

干预措施: Probiotics (Drug)

结局指标

主要结局

Improve the time to return of gut function in patient on enteral feeding in intensive care unit

时间窗: Time required to achieve maximum enteral feeding with a minimum of 48 hours

Probiotic/placebo administered once enteral feeding is started, and the hours needed to achieve maximum feeding is calculated in hours

次要结局

  • Inflammatory markers(7-14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ausama A Malik

Surgeon/Clinical Specialist

University of Malaya

研究点 (1)

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