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Probiotics in Enteral Feeding in Critically Ill Patients

Primary Purpose

Critical Illness, Dietary Modification, Probiotics

Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Critical illness, Dietary supplements, Gastrointestinal tract/physio-pathology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Probiotics

Arm Description

Patients on enteral feeding in intensive care units are administered a placebo

Patients on enteral feeding in intensive care unit are given a probiotic

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inflammatory markers
Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.

Full Information

First Posted
February 8, 2013
Last Updated
February 13, 2013
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT01792401
Brief Title
Probiotics in Enteral Feeding in Critically Ill Patients
Official Title
Probiotics in Enteral Feeding in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Dietary Modification, Probiotics, Gut Failure, Treatment Outcomes
Keywords
Critical illness, Dietary supplements, Gastrointestinal tract/physio-pathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients on enteral feeding in intensive care units are administered a placebo
Arm Title
Probiotics
Arm Type
Active Comparator
Arm Description
Patients on enteral feeding in intensive care unit are given a probiotic
Intervention Type
Drug
Intervention Name(s)
Probiotics
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Improve the time to return of gut function in patient on enteral feeding in intensive care unit
Description
Probiotic/placebo administered once enteral feeding is started, and the hours needed to achieve maximum feeding is calculated in hours
Time Frame
Time required to achieve maximum enteral feeding with a minimum of 48 hours
Secondary Outcome Measure Information:
Title
Inflammatory markers
Description
Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations.
Time Frame
7-14 days
Other Pre-specified Outcome Measures:
Title
Clinical Outcome
Description
Number of days in intensive care and number of ventilation days are calculated at the end of the study
Time Frame
Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ausama A Malik, MS,MBBS(Mal)
Organizational Affiliation
University Malaya Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kin Fah Chin, FRCS (Glasg)
Organizational Affiliation
University Malaya
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vineya Rai Hakumat Rai, M. Anes,MBBS
Organizational Affiliation
University Malaya
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chee Loong Yeap, MS,MBBS(Mal)
Organizational Affiliation
University Malaya
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peng Choong Lau, MS,MBBS(Mal)
Organizational Affiliation
University Malaya
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eng Hong Pok, MS,MBBS(Mal)
Organizational Affiliation
University Malaya
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gowri Rajandram, Phd(Aust)
Organizational Affiliation
University Malaya
Official's Role
Study Chair
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26777745
Citation
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.
Results Reference
derived

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Probiotics in Enteral Feeding in Critically Ill Patients

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