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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03186716
• Other study ID #: 2017670
• Status: Completed
• Phase: N/A
• First received: June 11, 2017
• Last updated: April 12, 2018
• Start date: June 11, 2017
• Est. completion date: March 11, 2018

Study information

• Verified date: April 2018
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 11, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Dietary Supplement:
• Colostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
• Maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

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. — View Citation

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). pii: E370. doi: 10.3390/nu9040370. — View Citation

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. — View Citation

Rathe M, Müller 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline plasma endotoxin concentration at 10 days	The levels of plasma endotoxin	baseline, Day 5, Day 10
Primary	Change from Baseline plasma zonulin concentration at 10 days	The levels of plasma zonulin	baseline, Day 5, Day 10
Secondary	Gastrointestinal complications	abdominal distention, vomiting, diarrhea and constipation	Day 10
Secondary	Mortality in ICU	Mortality rate	Day 10
Secondary	length of stay in ICU	Duration of stay in ICU	Day 10
Secondary	incidence of severe sepsis	according to the American College of Chest Physicians and the Society of Critical Care Medicine	Day 10