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Glutamine-induced recovery in intestinal barrier function by reducing bacterial translocation was demonstrated in previous studies. In this trial, intensive care unit patients with enteral feeding will receive either enteral glutamine or maltodextrin as placebo for 10 days and the effects of the intervention on intestinal permeability will be assessed.
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. The participants are 60 eligible hospitalized patients with enteral feeding in ICU, aged ≥ 18 years. Intervention patients will be received 0.3 g/kg/day of glutamine along with enteral formula for 10days and control patients will be received maltodextrin along with enteral formula for 10 days. Patients will be evaluated for plasma endotoxin and plasma zonulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutamin | Experimental | Intervention patients will be received enteral formula and glutamine 0.3 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 |
|---|---|---|---|---|
| Glutamin | Drug | Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma endotoxin concentration | The levels of plasma endotoxin | baseline, Day 5, Day 10 |
| Maximum plasma zonulin concentration | The levels of plasma zonulin | baseline, Day 5, Day 10 |
| Maximum plasma antiendotoxin IgG and Ig M concentration | The levels of plasma antiendotoxin IgG and Ig M concentration | baseline, Day 5, Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal complication | abdominal distention, vomiting, diarrhea and constipation | Day10 |
| Mortality in ICU | Mortality rate in ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Glutamin | The levels of serum Glutamin | baseline, Day 5, Day 10 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zahra Vahdat Shariatpanahi, MD, PhD | Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25810794 | Background | Rao R, Samak G. Role of Glutamine in Protection of Intestinal Epithelial Tight Junctions. J Epithel Biol Pharmacol. 2012 Jan;5(Suppl 1-M7):47-54. doi: 10.2174/1875044301205010047. No abstract available. | |
| 20631386 | Background | dos Santos Rd, Viana ML, Generoso SV, Arantes RE, Davisson Correia MI, Cardoso VN. Glutamine supplementation decreases intestinal permeability and preserves gut mucosa integrity in an experimental mouse model. JPEN J Parenter Enteral Nutr. 2010 Jul-Aug;34(4):408-13. doi: 10.1177/0148607110362530. |
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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 |
|---|---|
| C020654 | glutamin-(asparagin-)ase |
| D005973 | Glutamine |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Maltodextrin | Other | Maltodextrin mixed with water given via NG tube q 4 hours. |
|
| Day 10 |
| Length of stay in ICU | Duration of stay in ICU | Day 10 |
| Severe sepsis | according to the American College of Chest Physicians and the Society of Critical Care Medicine | Day 10 |
| 26773077 | Background | McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. |
| 16697087 | Background | Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J; DGEM (German Society for Nutritional Medicine); Ebner C, Hartl W, Heymann C, Spies C; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr. 2006 Apr;25(2):210-23. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11. |
| 15340021 | Background | D'Souza R, Powell-Tuck J. Glutamine supplements in the critically ill. J R Soc Med. 2004 Sep;97(9):425-7. doi: 10.1177/014107680409700904. No abstract available. |
| D021542 | Amino Acids, Neutral |