Probiotics in Enteral Feeding in Critically Ill Patients

NCT ID: NCT01792401

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Critical Illness; Dietary Modification; Probiotics; Gut Failure; Treatment Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Patients on enteral feeding in intensive care units are administered a placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Probiotics

Patients on enteral feeding in intensive care unit are given a probiotic

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: DRUG

Interventions

Probiotics

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Ausama A Malik

Surgeon/Clinical Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ausama A Malik, MS,MBBS(Mal)

Role: PRINCIPAL_INVESTIGATOR

University Malaya Medical Center

Kin Fah Chin, FRCS (Glasg)

Role: STUDY_CHAIR

University of Malaya

Vineya Rai Hakumat Rai, M. Anes,MBBS

Role: STUDY_CHAIR

University of Malaya

Chee Loong Yeap, MS,MBBS(Mal)

Role: STUDY_CHAIR

University of Malaya

Peng Choong Lau, MS,MBBS(Mal)

Role: STUDY_CHAIR

University of Malaya

Eng Hong Pok, MS,MBBS(Mal)

Role: STUDY_CHAIR

University of Malaya

Gowri Rajandram, Phd(Aust)

Role: STUDY_CHAIR

University of Malaya

Locations

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 26777745 (View on PubMed)

Other Identifiers

PEFCIP

Identifier Type: -

Identifier Source: org_study_id