NCT03186716

A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients

Effects of Colostrum Supplement on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The effects of colostrum on intestinal permeability 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 evaluated for plasma endotoxin and plasma zonulin.

Conditions

• Critical Illness

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

Timeline

• Start date: 2017-06-11
• Primary completion: 2018-01-25
• Completion: 2018-03-11
• First posted: 2017-06-14
• Last updated: 2018-04-17

Locations

1 site across 1 country: Iran