NCT03019250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

January 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed
Last Updated

November 13, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

January 10, 2017

Last Update Submit

November 9, 2018

Conditions

Critical IllnessInfection ComplicationMultiple Organ Dysfunction Syndrome

Keywords

ColostrumCritical Care OutcomesIntensive Care UnitInflammationInfectionmortality

Outcome Measures

Primary Outcomes (1)

  • Occurrence of infection

    Day 28

Secondary Outcomes (5)

  • 28-day Mortality

    Day 28

  • 6-month mortality

    month 6

  • Length of stay in ICU

    Day 28

  • Serum Immunity Markers

    baseline, Day 5, Day 10

  • Serum Inflammatory Markers

    baseline, Day 5, 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

ColostrumDIETARY_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
MaltodextrinDIETARY_SUPPLEMENT

Maltodextrin mixed with water given via NG tube Q 4 hours.

Maltodextrin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehran, Iran

Location

Related Publications (3)

  • 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: 15919136BACKGROUND

  • 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: 24571383BACKGROUND

  • 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: 22227281BACKGROUND

MeSH Terms

Conditions

Critical IllnessMultiple Organ FailureInflammationInfections

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsShock

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

January 10, 2017

First Posted

January 12, 2017

Study Start

January 15, 2017

Primary Completion

November 7, 2018

Study Completion

November 7, 2018

Last Updated

November 13, 2018

Record last verified: 2018-11

Locations

IR(1)