Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes 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 assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
Maltodextrin mixed with water given via NG tube Q 4 hours.
National Nutrition and Food Technology Research Institute
Tehran, Iran
Occurrence of infection
Time frame: Day 28
28-day Mortality
Time frame: Day 28
6-month mortality
Time frame: month 6
Length of stay in ICU
Time frame: Day 28
Serum Immunity Markers
Time frame: baseline, Day 5, Day 10
Serum Inflammatory Markers
Time frame: baseline, Day 5, Day 10
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