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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colostrum | Experimental | Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs. |
|
| Maltodextrin | Placebo Comparator | Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colostrum | Dietary Supplement | Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of infection | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day Mortality | Day 28 | |
| 6-month mortality | month 6 | |
| Length of stay in ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghazaleh Eslamian, MS,PhDcandid | National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15919136 | Background | Kim JW, Jeon WK, Kim EJ. Combined effects of bovine colostrum and glutamine in diclofenac-induced bacterial translocation in rat. Clin Nutr. 2005 Oct;24(5):785-93. doi: 10.1016/j.clnu.2005.04.004. | |
| 24571383 | Background | Rathe M, Muller K, Sangild PT, Husby S. Clinical applications of bovine colostrum therapy: a systematic review. Nutr Rev. 2014 Apr;72(4):237-54. doi: 10.1111/nure.12089. Epub 2014 Feb 26. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D009102 | Multiple Organ Failure |
| D007249 | Inflammation |
| D007239 | Infections |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Maltodextrin mixed with water given via NG tube Q 4 hours. |
|
| Day 28 |
| Serum Immunity Markers | baseline, Day 5, Day 10 |
| Serum Inflammatory Markers | baseline, Day 5, Day 10 |
| 22227281 | Background | Benson KF, Carter SG, Patterson KM, Patel D, Jensen GS. A novel extract from bovine colostrum whey supports anti-bacterial and anti-viral innate immune functions in vitro and in vivo: I. Enhanced immune activity in vitro translates to improved microbial clearance in animal infection models. Prev Med. 2012 May;54 Suppl:S116-23. doi: 10.1016/j.ypmed.2011.12.023. Epub 2011 Dec 28. |