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Completed

NCT Number: NCT03019250

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

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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Key information

Conditions

Critical Illness Disease Attributes Infection Complication Infections Inflammation Multiple Organ Dysfunction Syndrome Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Nutrition and Food Technology Research Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colostrum

Dietary Supplement

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

Other names: Bovine Colostrum

Maltodextrin

Dietary Supplement

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

Primary outcomes

  1. Occurrence of infection

    Time frame: Day 28

Secondary outcomes

  1. 28-day Mortality

    Time frame: Day 28

  2. 6-month mortality

    Time frame: month 6

  3. Length of stay in ICU

    Time frame: Day 28

  4. Serum Immunity Markers

    Time frame: baseline, Day 5, Day 10

  5. Serum Inflammatory Markers

    Time frame: baseline, Day 5, Day 10

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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