Probiotics in Enteral Feeding in Critically Ill Patients

U

University of Malaya

Status and phase

Completed
Phase 2

Conditions

Gut Failure
Critical Illness
Dietary Modification
Treatment Outcomes
Probiotics

Treatments

Drug: Placebo
Drug: Probiotics

Study type

Interventional

Funder types

Other

Identifiers

NCT01792401
PEFCIP

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

49 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Patients on enteral feeding in intensive care units are administered a placebo
Treatment:
Drug: Placebo
Probiotics
Active Comparator group
Description:
Patients on enteral feeding in intensive care unit are given a probiotic
Treatment:
Drug: Probiotics

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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