Clinical trial NCT03019250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Infection Complication
Multiple Organ Dysfunction Syndrome
Keywords: Colostrum
Critical Care Outcomes
Intensive Care Unit
Inflammation
Infection
mortality
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Occurrence of infection
timeFrame: Day 28
Secondary outcomes:
measure: 28-day Mortality
timeFrame: Day 28
measure: 6-month mortality
timeFrame: month 6
measure: Length of stay in ICU
timeFrame: Day 28
measure: Serum Immunity Markers
timeFrame: baseline, Day 5, Day 10
measure: Serum Inflammatory Markers
timeFrame: baseline, Day 5, Day 10
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
affiliation: National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Ghazaleh Eslamian, MS,PhDcandid
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.