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Completed

NCT Number: NCT01792401

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.

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Key information

Conditions

Critical Illness Dietary Modification Disease Attributes Gut Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Probiotics Treatment Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Malaya Medical Center

Kuala Lumpur, 59100, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Drug

Placebo

Drug

Primary outcomes

  1. Improve the time to return of gut function in patient on enteral feeding in intensive care unit

    Time frame: 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 outcomes

  1. Inflammatory markers

    Time frame: 7-14 days

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

Other outcomes

  1. Clinical Outcome

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2013
Registry last updated
Feb 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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