Probiotics in Enteral Feeding in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Probiotics in Enteral Feeding in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792401
• Other study ID #: PEFCIP
• Status: Completed
• Phase: Phase 2
• First received: February 8, 2013
• Last updated: February 13, 2013
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Dietary Modification
• Gut Failure
• Probiotics
• Treatment Outcomes

Intervention

Drug:
• Probiotics

• Placebo

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Outcome	Number of days in intensive care and number of ventilation days are calculated at the end of the study	Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days	No
Primary	Improve the time to return of gut function in patient on enteral feeding in intensive care unit	Probiotic/placebo administered once enteral feeding is started, and the hours needed to achieve maximum feeding is calculated in hours	Time required to achieve maximum enteral feeding with a minimum of 48 hours	No
Secondary	Inflammatory markers	Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.	7-14 days	No