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Probiotics in Enteral Feeding in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01792401
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Ausama A Malik, 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.

Condition or disease Intervention/treatment Phase
Critical Illness Dietary Modification Probiotics Gut Failure Treatment Outcomes Drug: Probiotics Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics in Enteral Feeding in Critically Ill Patients
Study Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792401


Locations
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Malaysia
University Malaya Medical Center
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ausama A Malik, Surgeon/Clinical Specialist, University of Malaya
ClinicalTrials.gov Identifier: NCT01792401    
Other Study ID Numbers: PEFCIP
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Ausama A Malik, University of Malaya:
Critical illness
Dietary supplements
Gastrointestinal tract/physio-pathology
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes