Probiotics in Enteral Feeding in Critically Ill Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Patients on enteral feeding in intensive care units are administered a placebo |
Drug: Placebo
|
| Active Comparator: Probiotics Patients on enteral feeding in intensive care unit are given a probiotic |
Drug: Probiotics
|
Outcome Measures
Primary Outcome Measures
- Improve the time to return of gut function in patient on enteral feeding in intensive care unit [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
Secondary Outcome Measures
- Inflammatory markers [7-14 days]
Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.
Other Outcome Measures
- Clinical Outcome [Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days]
Number of days in intensive care and number of ventilation days are calculated at the end of the study
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Admitted to intensive care unit
-
Expected stay of more than 48 hours
-
On enteral feeding
-
Consent obtained from patient/relative
Exclusion Criteria:
-
Patients on immuno-suppressive drugs
-
Patients with hematological diseases
-
Pregnant females
-
Do not consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Malaya Medical Center | Kuala Lumpur | Malaysia | 59100 |
Sponsors and Collaborators
- University of Malaya
Investigators
- Principal Investigator: Ausama A Malik, MS,MBBS(Mal), University Malaya Medical Center
- Study Chair: Kin Fah Chin, FRCS (Glasg), University Malaya
- Study Chair: Vineya Rai Hakumat Rai, M. Anes,MBBS, University Malaya
- Study Chair: Chee Loong Yeap, MS,MBBS(Mal), University Malaya
- Study Chair: Peng Choong Lau, MS,MBBS(Mal), University Malaya
- Study Chair: Eng Hong Pok, MS,MBBS(Mal), University Malaya
- Study Chair: Gowri Rajandram, Phd(Aust), University Malaya
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEFCIP