A Trial of Enteral Colostrum on Clinical Outcomes in Critically Ill Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03019250|
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : November 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness Infection Complication Multiple Organ Dysfunction Syndrome||Dietary Supplement: Colostrum Dietary Supplement: Maltodextrin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Occurrence of infection [ Time Frame: Day 28 ]
- 28-day Mortality [ Time Frame: Day 28 ]
- 6-month mortality [ Time Frame: month 6 ]
- Length of stay in ICU [ Time Frame: Day 28 ]
- Serum Immunity Markers [ Time Frame: baseline, Day 5, Day 10 ]
- Serum Inflammatory Markers [ Time Frame: baseline, Day 5, Day 10 ]
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
|Iran, Islamic Republic of|
|National Nutrition and Food Technology Research Institute|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Ghazaleh Eslamian, MS,PhDcandid||National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran|