Clinical trial NCT01792401: Probiotics in Enteral Feeding in Critically Ill Patients
Official title: Probiotics in Enteral Feeding in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Critical Illness
Dietary Modification
Probiotics
Gut Failure
Treatment Outcomes
Keywords: Critical illness
Dietary supplements
Gastrointestinal tract/physio-pathology
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improve the time to return of gut function in patient on enteral feeding in intensive care unit
timeFrame: Time required to achieve maximum enteral feeding with a minimum of 48 hours
Secondary outcomes:
measure: Inflammatory markers
timeFrame: 7-14 days
Other outcomes:
measure: Clinical Outcome
timeFrame: Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
Study officials:
affiliation: University Malaya Medical Center
name: Ausama A Malik, MS,MBBS(Mal)
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Kin Fah Chin, FRCS (Glasg)
role: STUDY_CHAIR
affiliation: University of Malaya
name: Vineya Rai Hakumat Rai, M. Anes,MBBS
role: STUDY_CHAIR
affiliation: University of Malaya
name: Chee Loong Yeap, MS,MBBS(Mal)
role: STUDY_CHAIR
affiliation: University of Malaya
name: Peng Choong Lau, MS,MBBS(Mal)
role: STUDY_CHAIR
affiliation: University of Malaya
name: Eng Hong Pok, MS,MBBS(Mal)
role: STUDY_CHAIR
affiliation: University of Malaya
name: Gowri Rajandram, Phd(Aust)
role: STUDY_CHAIR
References:
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.