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

NCT03186716 | Completed DMC

• 1 other identifier: 2017670
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Colostrum; Enteral Nutrition; Intestinal Permeability; Intensive Care Unit

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Gastrointestinal complications

  Day 10

• Mortality in ICU

  Day 10

• length of stay in ICU

  Day 10

• incidence of severe sepsis

  Day 10

Study Arms (2)

Colostrum

EXPERIMENTAL

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

Maltodextrin

PLACEBO COMPARATOR

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

Interventions

Colostrum DIETARY_SUPPLEMENT

Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.

Also known as: Bovine Colostrum

Colostrum

Maltodextrin DIETARY_SUPPLEMENT

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

Location

Related Publications (6)

• 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.

  PMID: 15919136 BACKGROUND

• 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.

  PMID: 24571383 BACKGROUND

• 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.

  PMID: 22227281 BACKGROUND

• 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.

  PMID: 28397754 BACKGROUND

• 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.

  PMID: 25349570 BACKGROUND

• 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.

  PMID: 30551120 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghazaleh Eslamian, MS,PhDcandid

  National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2017
• First Posted: June 14, 2017
• Study Start: June 11, 2017
• Primary Completion: January 25, 2018
• Study Completion: March 11, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

IR (1)