Probiotics in Enteral Feeding in Critically Ill Patients

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Probiotics; Dietary Modification; Treatment Outcomes; Gut Failure
• Intervention / Treatment: Drug: Placebo; Drug: Probiotics

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Malik AA, Rajandram R, Tah PC, Hakumat-Rai VR, Chin KF. Microbial cell preparation in enteral feeding in critically ill patients: A randomized, double-blind, placebo-controlled clinical trial. J Crit Care. 2016 Apr;32:182-8. doi: 10.1016/j.jcrc.2015.12.008. Epub 2015 Dec 15.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Critical illness; Dietary supplements; Gastrointestinal tract/physio-pathology
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: PEFCIP