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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Dietary Supplement: Colostrum; Dietary Supplement: Maltodextrin

• Registration Number: NCT03186716
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Study Timeline

• Study Start: 2017-06-11
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Primary Completion: 2018-01-25
• Study Completion: 2018-03-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colostrum	Colostrum	Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
Maltodextrin	Maltodextrin	Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Primary Outcome Measures

Name	Time	Method
Change from Baseline plasma zonulin concentration at 10 days	baseline, Day 5, Day 10	The levels of plasma zonulin
Change from Baseline plasma endotoxin concentration at 10 days	baseline, Day 5, Day 10	The levels of plasma endotoxin

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of