Critical Illness Clinical Trial
Official title:
Probiotics in Enteral Feeding in Critically Ill Patients
Verified date | February 2013 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | Malaysia: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malaysia | University Malaya Medical Center | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Outcome | Number of days in intensive care and number of ventilation days are calculated at the end of the study | Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days | No |
Primary | 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 | No |
Secondary | Inflammatory markers | Measure of inflammatory markers are obtained from patients at the start and at the end of probiotic/placebo administrations. | 7-14 days | No |
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