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A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients

Primary Purpose

Critical Illness, Infection Complication, Multiple Organ Dysfunction Syndrome

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, Critical Care Outcomes, Intensive Care Unit, Inflammation, Infection, mortality

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

Occurrence of infection

Secondary Outcome Measures

28-day Mortality
6-month mortality
Length of stay in ICU
Serum Immunity Markers
Serum Inflammatory Markers

Full Information

First Posted
January 10, 2017
Last Updated
November 9, 2018
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03019250
Brief Title
A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients
Official Title
Effects of Colostrum Supplement on Inflammatory and Growth Factors, Immune System Function and Clinical Outcomes in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2017 (Actual)
Primary Completion Date
November 7, 2018 (Actual)
Study Completion Date
November 7, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Enteral administration of immune-modulating nutrients such as glutamine, omega-3 fatty acids, selenium, and antioxidants has been suggested to reduce infections and improve recovery from critical illness. However, the effects of colostrum on clinical outcomes 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 assessed for occurrence of new infection, organ failure, duration of stay in ICU, 28 days and 6 months mortality and inflammatory and immune markers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Infection Complication, Multiple Organ Dysfunction Syndrome
Keywords
Colostrum, Critical Care Outcomes, Intensive Care Unit, Inflammation, Infection, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (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
Maltodextrin mixed with water given via NG tube Q 4 hours.
Primary Outcome Measure Information:
Title
Occurrence of infection
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
28-day Mortality
Time Frame
Day 28
Title
6-month mortality
Time Frame
month 6
Title
Length of stay in ICU
Time Frame
Day 28
Title
Serum Immunity Markers
Time Frame
baseline, Day 5, Day 10
Title
Serum Inflammatory Markers
Time Frame
baseline, Day 5, 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
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A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients

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