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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Dietary supplement: Colostrum; Dietary supplement: Maltodextrin

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Colostrum; 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; Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.; Other Names: Bovine Colostrum
PLACEBO_COMPARATOR: Maltodextrin; 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; Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute
• Investigators: Principal Investigator: Ghazaleh Eslamian, MS,PhDcandid, National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications and helpful links

General Publications

• Kim JW, Jeon WK, Kim EJ. Combined effects of bovine colostrum and glutamine in diclofenac-induced bacterial translocation in rat. Clin Nutr. 2005 Oct;24(5):785-93. doi: 10.1016/j.clnu.2005.04.004.
• Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26.
• Benson KF, Carter SG, Patterson KM, Patel D, Jensen GS. A novel extract from bovine colostrum whey supports anti-bacterial and anti-viral innate immune functions in vitro and in vivo: I. Enhanced immune activity in vitro translates to improved microbial clearance in animal infection models. Prev Med. 2012 May;54 Suppl:S116-23. doi: 10.1016/j.ypmed.2011.12.023. Epub 2011 Dec 28.
• Halasa M, Maciejewska D, Baskiewicz-Halasa M, Machalinski B, Safranow K, Stachowska E. Oral Supplementation with Bovine Colostrum Decreases Intestinal Permeability and Stool Concentrations of Zonulin in Athletes. Nutrients. 2017 Apr 8;9(4):370. doi: 10.3390/nu9040370.
• Yoon JY, Park SJ, Cheon JH. Effect of Colostrum on the Symptoms and Mucosal Permeability in Patients with Irritable Bowel Syndrome: A Randomized Placebo-controlled Study. Intest Res. 2014 Jan;12(1):80-2. doi: 10.5217/ir.2014.12.1.80. Epub 2014 Jan 28. No abstract available.
• Eslamian G, Ardehali SH, Baghestani AR, Vahdat Shariatpanahi Z. Effects of early enteral bovine colostrum supplementation on intestinal permeability in critically ill patients: A randomized, double-blind, placebo-controlled study. Nutrition. 2019 Apr;60:106-111. doi: 10.1016/j.nut.2018.10.013. Epub 2018 Oct 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2017
• Primary Completion (ACTUAL): January 25, 2018
• Study Completion (ACTUAL): March 11, 2018

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Enteral Nutrition; Intestinal Permeability; Colostrum
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2017670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No