NCT03019250

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Infection Complication
• Multiple Organ Dysfunction Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Colostrum	Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
DIETARY_SUPPLEMENT	Maltodextrin	Maltodextrin mixed with water given via NG tube Q 4 hours.

Timeline

• Start date: 2017-01-15
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2017-01-12
• Last updated: 2018-11-13

Locations

1 site across 1 country: Iran