Probiotics in Enteral Feeding in Critically Ill Patients

Phase 2

Completed

• Conditions: Critical Illness; Dietary Modification; Probiotics; Gut Failure; Treatment Outcomes
• Interventions: Drug: Placebo; Drug: Probiotics

• Registration Number: NCT01792401
• Lead Sponsor: University of Malaya

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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-13
• Last Update Submitted: 2013-02-13
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients on enteral feeding in intensive care units are administered a placebo
Probiotics	Probiotics	Patients on enteral feeding in intensive care unit are given a probiotic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Inflammatory markers	7-14 days	Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.

Trial Locations

Locations (1)

University Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia