A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients

Study Overview
=================
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.

Official Title
-----------------
Effects of Colostrum Supplement on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Dietary Supplement: Colostrum
* Dietary Supplement: Maltodextrin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colostrum<br>Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs. | Dietary Supplement: Colostrum<br>* Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.<br>* Other names: Bovine Colostrum;|
| Placebo Comparator: Maltodextrin<br>Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs. | Dietary Supplement: Maltodextrin<br>* Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline plasma endotoxin concentration at 10 days | The levels of plasma endotoxin | baseline, Day 5, Day 10 | 
| Change from Baseline plasma zonulin concentration at 10 days | The levels of plasma zonulin | baseline, Day 5, Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal complications | abdominal distention, vomiting, diarrhea and constipation | Day 10 | 
| Mortality in ICU | Mortality rate | Day 10 | 
| length of stay in ICU | Duration of stay in ICU | Day 10 | 
| incidence of severe sepsis | according to the American College of Chest Physicians and the Society of Critical Care Medicine | Day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colostrum, Enteral Nutrition, Intestinal Permeability, Intensive Care Unit