search
Back to results

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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Colostrum
Maltodextrin
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Colostrum, Enteral Nutrition, Intestinal Permeability, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Nutrition and Food Technology Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colostrum

Maltodextrin

Arm Description

Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.

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

Outcomes

Primary Outcome Measures

Change from Baseline plasma endotoxin concentration at 10 days
The levels of plasma endotoxin
Change from Baseline plasma zonulin concentration at 10 days
The levels of plasma zonulin

Secondary Outcome Measures

Gastrointestinal complications
abdominal distention, vomiting, diarrhea and constipation
Mortality in ICU
Mortality rate
length of stay in ICU
Duration of stay in ICU
incidence of severe sepsis
according to the American College of Chest Physicians and the Society of Critical Care Medicine

Full Information

First Posted
June 11, 2017
Last Updated
April 12, 2018
Sponsor
National Nutrition and Food Technology Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03186716
Brief Title
A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients
Official Title
Effects of Colostrum Supplement on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 11, 2017 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
March 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Colostrum, Enteral Nutrition, Intestinal Permeability, Intensive Care Unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colostrum
Arm Type
Experimental
Arm Description
Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Intervention Type
Dietary Supplement
Intervention Name(s)
Colostrum
Other Intervention Name(s)
Bovine Colostrum
Intervention Description
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Primary Outcome Measure Information:
Title
Change from Baseline plasma endotoxin concentration at 10 days
Description
The levels of plasma endotoxin
Time Frame
baseline, Day 5, Day 10
Title
Change from Baseline plasma zonulin concentration at 10 days
Description
The levels of plasma zonulin
Time Frame
baseline, Day 5, Day 10
Secondary Outcome Measure Information:
Title
Gastrointestinal complications
Description
abdominal distention, vomiting, diarrhea and constipation
Time Frame
Day 10
Title
Mortality in ICU
Description
Mortality rate
Time Frame
Day 10
Title
length of stay in ICU
Description
Duration of stay in ICU
Time Frame
Day 10
Title
incidence of severe sepsis
Description
according to the American College of Chest Physicians and the Society of Critical Care Medicine
Time Frame
Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazaleh Eslamian, MS,PhDcandid
Organizational Affiliation
National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Nutrition and Food Technology Research Institute
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15919136
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. doi: 10.1016/j.clnu.2005.04.004.
Results Reference
background
PubMed Identifier
24571383
Citation
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.
Results Reference
background
PubMed Identifier
22227281
Citation
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.
Results Reference
background
PubMed Identifier
28397754
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):370. doi: 10.3390/nu9040370.
Results Reference
background
PubMed Identifier
25349570
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. No abstract available.
Results Reference
background
PubMed Identifier
30551120
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs