Probiotics in Enteral Feeding in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Probiotics in Enteral Feeding in Critically Ill Patients

Conditions
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Critical Illness, Dietary Modification, Probiotics, Gut Failure, Treatment Outcomes

Intervention / Treatment
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* Drug: Probiotics
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients on enteral feeding in intensive care units are administered a placebo | Drug: Placebo<br> <br> |
| Active Comparator: Probiotics<br>Patients on enteral feeding in intensive care unit are given a probiotic | Drug: Probiotics<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, Dietary supplements, Gastrointestinal tract/physio-pathology