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

Not Applicable

Completed

• Conditions: Multiple Organ Dysfunction Syndrome; Critical Illness; Infection Complication

• Registration Number: NCT03019250
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-01-15
• Status Verified: 2018-11
• Primary Completion: 2018-11-07
• Study Completion: 2018-11-07
• Last Update Submitted: 2018-11-09
• Last Update Posted: 2018-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of infection	Day 28

Secondary Outcome Measures

Name	Time	Method
Serum Immunity Markers	baseline, Day 5, Day 10
Serum Inflammatory Markers	baseline, Day 5, Day 10
28-day Mortality	Day 28
Length of stay in ICU	Day 28
6-month mortality	month 6

Trial Locations

Locations (1)

National Nutrition and Food Technology Research Institute; 🇮🇷 Tehran, Iran, Islamic Republic of