The effects of colostrum on intestinal permeability in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.
A randomized, double blind, controlled trial will be conducted in general intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be evaluated for plasma endotoxin and plasma zonulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
National Nutrition and Food Technology Research Institute
Tehran, Iran
Change from Baseline plasma endotoxin concentration at 10 days
The levels of plasma endotoxin
Time frame: baseline, Day 5, Day 10
Change from Baseline plasma zonulin concentration at 10 days
The levels of plasma zonulin
Time frame: baseline, Day 5, Day 10
Gastrointestinal complications
abdominal distention, vomiting, diarrhea and constipation
Time frame: Day 10
Mortality in ICU
Mortality rate
Time frame: Day 10
length of stay in ICU
Duration of stay in ICU
Time frame: Day 10
incidence of severe sepsis
according to the American College of Chest Physicians and the Society of Critical Care Medicine
Time frame: Day 10
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