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The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients

NCT02144168 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-05-21

No results posted yet for this study

Summary

Primary objective of this study is to measure the change of concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition.Our null hypothesis is that there is no difference in the concentration of faecal bifidobacteria between critically ill patients who receive enteral formula with and without prebiotics during enteral nutrition (EN). Three faecal samples will be taken from the patient. First faecal sample is the first stool after initiation of EN and second sample is taken seven days after the initial sample and the third faecal sample is taken at day 14 after initial sample. Patient will be randomized to receive either of described formula after baseline (first) stool sample is obtained. Patient will be monitored up to 14 days after the initial stool sample is obtained.

Conditions

  • Diarrhoea

Interventions

DIETARY_SUPPLEMENT

Prebiotics-free enteral formula

Patient will be given Osmolite 1 cal for 2 weeks after baseline stool sample obtained

DIETARY_SUPPLEMENT

Prebiotics containing enteral formula

Patient will be given Ensure Fos for 2 weeks after baseline stool sample obtained

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Mazuin Kamarul Zaman, BSc (RD) · University of Malaya

  • Hazreen Abdul Majid, BSc(RD),PhD · University of Malaya

  • Vineya Rai Hakumat Rai, MBBS · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144168 on ClinicalTrials.gov