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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.
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.
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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 |
|---|---|---|
| Change from Baseline plasma endotoxin concentration at 10 days | The levels of plasma endotoxin | baseline, Day 5, Day 10 |
| Change from Baseline plasma zonulin concentration at 10 days | The levels of plasma zonulin | baseline, Day 5, Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal complications | abdominal distention, vomiting, diarrhea and constipation | Day 10 |
| Mortality in ICU | Mortality rate | Day 10 |
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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 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs. |
|
| length of stay in ICU | Duration of stay in ICU | Day 10 |
| incidence of severe sepsis | according to the American College of Chest Physicians and the Society of Critical Care Medicine | 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. |
| 28397754 | Background | Halasa M, Maciejewska D, Baskiewicz-Halasa M, Machalinski B, Safranow K, Stachowska E. Oral Supplementation with Bovine Colostrum Decreases Intestinal Permeability and Stool Concentrations of Zonulin in Athletes. Nutrients. 2017 Apr 8;9(4):370. doi: 10.3390/nu9040370. |
| 25349570 | Background | Yoon JY, Park SJ, Cheon JH. Effect of Colostrum on the Symptoms and Mucosal Permeability in Patients with Irritable Bowel Syndrome: A Randomized Placebo-controlled Study. Intest Res. 2014 Jan;12(1):80-2. doi: 10.5217/ir.2014.12.1.80. Epub 2014 Jan 28. No abstract available. |
| 30551120 | Derived | Eslamian G, Ardehali SH, Baghestani AR, Vahdat Shariatpanahi Z. Effects of early enteral bovine colostrum supplementation on intestinal permeability in critically ill patients: A randomized, double-blind, placebo-controlled study. Nutrition. 2019 Apr;60:106-111. doi: 10.1016/j.nut.2018.10.013. Epub 2018 Oct 12. |