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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-15

Study Completion Date

2018-11-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness Infection Complication Multiple Organ Dysfunction Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colostrum

Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.

Group Type EXPERIMENTAL

Colostrum

Intervention Type DIETARY_SUPPLEMENT

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

Maltodextrin

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Colostrum

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

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Bovine Colostrum

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No