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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019250
• Other study ID #: 2016670
• Status: Completed
• Phase: N/A
• Start date: January 15, 2017
• Est. completion date: November 7, 2018

Study information

• Verified date: November 2018
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 7, 2018
• Est. primary completion date: November 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Infection Complication
• Multiple Organ Dysfunction Syndrome
• Multiple Organ Failure

Intervention

Dietary Supplement:
• Colostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
• Maltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours.

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

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. — View 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. — View Citation

Rathe M, Müller 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of infection		Day 28
Secondary	28-day Mortality		Day 28
Secondary	6-month mortality		month 6
Secondary	Length of stay in ICU		Day 28
Secondary	Serum Immunity Markers		baseline, Day 5, Day 10
Secondary	Serum Inflammatory Markers		baseline, Day 5, Day 10