NCT01792401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

February 8, 2013

Last Update Submit

February 13, 2013

Conditions

Critical IllnessDietary ModificationProbioticsGut FailureTreatment Outcomes

Keywords

Critical illnessDietary supplementsGastrointestinal tract/physio-pathology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Inflammatory markers

    7-14 days

Other Outcomes (1)

  • Clinical Outcome

    Patients will be followed up throughtout their duration of intensive care stay, or a minimum of 1-14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Probiotics

ACTIVE COMPARATOR

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

Drug: Probiotics

Interventions

ProbioticsDRUG
Probiotics
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to intensive care unit
  • Expected stay of more than 48 hours
  • On enteral feeding
  • Consent obtained from patient/relative

You may not qualify if:

  • Patients on immuno-suppressive drugs
  • Patients with hematological diseases
  • Pregnant females
  • Do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 26777745DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ausama A Malik, MS,MBBS(Mal)

    University Malaya Medical Center

    PRINCIPAL INVESTIGATOR

  • Kin Fah Chin, FRCS (Glasg)

    University of Malaya

    STUDY CHAIR

  • Vineya Rai Hakumat Rai, M. Anes,MBBS

    University of Malaya

    STUDY CHAIR

  • Chee Loong Yeap, MS,MBBS(Mal)

    University of Malaya

    STUDY CHAIR

  • Peng Choong Lau, MS,MBBS(Mal)

    University of Malaya

    STUDY CHAIR

  • Eng Hong Pok, MS,MBBS(Mal)

    University of Malaya

    STUDY CHAIR

  • Gowri Rajandram, Phd(Aust)

    University of Malaya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgeon/Clinical Specialist

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 15, 2013

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

MY(1)