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Trial record 19 of 561 for:    maltodextrin

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

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ClinicalTrials.gov Identifier: NCT03019250
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ghazaleh Eslamian, 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.

Condition or disease Intervention/treatment Phase
Critical Illness Infection Complication Multiple Organ Dysfunction Syndrome Dietary Supplement: Colostrum Dietary Supplement: Maltodextrin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : November 7, 2018
Actual Study Completion Date : November 7, 2018

Arm Intervention/treatment
Experimental: Colostrum
Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
Dietary Supplement: Colostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
Other Name: Bovine Colostrum

Placebo Comparator: Maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Dietary Supplement: Maltodextrin
Maltodextrin mixed with water given via NG tube Q 4 hours.




Primary Outcome Measures :
  1. Occurrence of infection [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019250


Locations
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Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
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Principal Investigator: Ghazaleh Eslamian, MS,PhDcandid National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications:
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Responsible Party: Ghazaleh Eslamian, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03019250     History of Changes
Other Study ID Numbers: 2016670
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ghazaleh Eslamian, National Nutrition and Food Technology Institute:
Colostrum
Critical Care Outcomes
Intensive Care Unit
Inflammation
Infection
mortality
Additional relevant MeSH terms:
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Critical Illness
Multiple Organ Failure
Disease Attributes
Pathologic Processes
Shock