The Effect of Enteral Nutrition Supplemented With Prebiotics on Colonic Microbiota in the Critically Ill Patients
PrebioticFOS
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMay 21, 2014
May 1, 2014
8 months
May 19, 2014
May 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of diarrhoea
up to 14 days post intervention
Secondary Outcomes (1)
Changes in faecal microbiota
baseline, 1 week & 2 weeks after baseline sample
Other Outcomes (1)
Changes in short chain fatty acid
baseline, 1 week & 2 weeks after baseline sample
Study Arms (2)
prebiotics-free enteral formula
ACTIVE COMPARATORPatients in this arm will be receiving standard, prebiotics-free enteral formula : Osmolite 1 cal
prebiotics containing enteral formula
EXPERIMENTALPatients in this arm will be receiving prebiotics containing enteral formula:Ensure Fos for 14 days
Interventions
Patient will be given Osmolite 1 cal for 2 weeks after baseline stool sample obtained
Patient will be given Ensure Fos for 2 weeks after baseline stool sample obtained
Eligibility Criteria
You may qualify if:
- Patients receiving exclusive EN , nasogastric, continuous infusion
- Adult patients , 18 years old and above
- Critically ill patients
- Expected to require EN more than five days(Bleichner et al., 1997)
You may not qualify if:
- Patients with gastrointestinal disease (Sokol et al., 2006) or GIT surgery
- Patients receiving lactulose (Bouhnik et al., 2004)
- Currently under chemotherapy treatment (Kapkac et al., 2003)
- Patients who had received prebiotics and probiotics supplements within the previous one month
- Patients who have diarrhoea, 3 consecutive days (Majid et al, 2013)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 50603, Malaysia
Related Publications (6)
Bleichner G, Blehaut H, Mentec H, Moyse D. Saccharomyces boulardii prevents diarrhea in critically ill tube-fed patients. A multicenter, randomized, double-blind placebo-controlled trial. Intensive Care Med. 1997 May;23(5):517-23. doi: 10.1007/s001340050367.
PMID: 9201523BACKGROUNDSokol H, Seksik P, Rigottier-Gois L, Lay C, Lepage P, Podglajen I, Marteau P, Dore J. Specificities of the fecal microbiota in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Feb;12(2):106-11. doi: 10.1097/01.MIB.0000200323.38139.c6.
PMID: 16432374BACKGROUNDBouhnik Y, Attar A, Joly FA, Riottot M, Dyard F, Flourie B. Lactulose ingestion increases faecal bifidobacterial counts: a randomised double-blind study in healthy humans. Eur J Clin Nutr. 2004 Mar;58(3):462-6. doi: 10.1038/sj.ejcn.1601829.
PMID: 14985684BACKGROUNDKapkac, M., Erikoglu, M., Tuncyurek, P., Ersin, S., Esassolak, M., Alkanat, M., & Sipahioglu, O. (2003). Fiber enriched diets and radiation induced injury of the gut. Nutrition research (New York, N.Y.), 23(1), 77-83
BACKGROUNDWhelan K, Judd PA, Preedy VR, Taylor MA. Covert assessment of concurrent and construct validity of a chart to characterize fecal output and diarrhea in patients receiving enteral nutrition. JPEN J Parenter Enteral Nutr. 2008 Mar-Apr;32(2):160-8. doi: 10.1177/0148607108314769.
PMID: 18407909BACKGROUNDMajid HA, Cole J, Emery PW, Whelan K. Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.
PMID: 24290345BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mazuin Kamarul Zaman, BSc (RD)
University of Malaya
- PRINCIPAL INVESTIGATOR
Hazreen Abdul Majid, BSc(RD),PhD
University of Malaya
- PRINCIPAL INVESTIGATOR
Vineya Rai Hakumat Rai, MBBS
University of Malaya
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mrs
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 21, 2014
Study Start
January 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
May 21, 2014
Record last verified: 2014-05