Critical Illness
Conditions
Keywords
Colostrum, Enteral Nutrition, Intestinal Permeability, Intensive Care Unit
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTColostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
DIETARY_SUPPLEMENTMaltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>18 years old) admitted to ICU * Start of study intervention within 48 hours after ICU admission * Expected to require enteral nutrition for at least 72 hours aiming for full enteral nutrition and receive at least 80 percent of enteral formula during the first 48 hour * Written informed consent of patient or written informed consent of legal representative
Exclusion criteria
* Enrollment in a related ICU interventional study * Requiring other specific enteral nutrition for medical reason * Death or Discharge before 5th day * Having any contra-indication to receive enteral nutrition * Pregnant patients or lactating with the intent to breastfeed * BMI \<18 or \> 40.0 kg/m2 * Have life expectancy of \<6 mo * Patients who are moribund * History of allergy or intolerance to the study product components * Receiving colostrum during two weeks before start study product * Have other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline plasma endotoxin concentration at 10 days | baseline, Day 5, Day 10 | The levels of plasma endotoxin |
| Change from Baseline plasma zonulin concentration at 10 days | baseline, Day 5, Day 10 | The levels of plasma zonulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal complications | Day 10 | abdominal distention, vomiting, diarrhea and constipation |
| Mortality in ICU | Day 10 | Mortality rate |
| length of stay in ICU | Day 10 | Duration of stay in ICU |
| incidence of severe sepsis | Day 10 | according to the American College of Chest Physicians and the Society of Critical Care Medicine |
Countries
Iran
Outcome results
None listed