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

Sponsor

National Nutrition and Food Technology Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03019250

Collaborator

(none)

200

Enrollment

Location

Arms

21.7

Actual Duration (Months)

9.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Infection Complication Multiple Organ Dysfunction Syndrome	Dietary Supplement: Colostrum Dietary Supplement: Maltodextrin	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 15, 2017

Actual Primary Completion Date :

Nov 7, 2018

Actual Study Completion Date :

Nov 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Colostrum 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 Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs. Other Names: Bovine Colostrum
Placebo Comparator: Maltodextrin 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 Maltodextrin mixed with water given via NG tube Q 4 hours.

Arm

Intervention/Treatment

Experimental: Colostrum

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

Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.

Other Names:

Bovine Colostrum

Placebo Comparator: Maltodextrin

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

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

Outcome Measures

Primary Outcome Measures

Occurrence of infection [Day 28]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Nutrition and Food Technology Research Institute	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

Principal Investigator: Ghazaleh Eslamian, MS,PhDcandid, National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran