Trials / Completed
CompletedNCT01792401
Probiotics in Enteral Feeding in Critically Ill Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- University of Malaya · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Probiotics | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2013-02-15
- Last updated
- 2013-02-15
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT01792401. Inclusion in this directory is not an endorsement.