Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Enteral Glutamine on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit

Conditions
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Critical Illness, Enteral Nutrition, Intestinal Permeability

Intervention / Treatment
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* Drug: Glutamin
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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 moribond Liver cirrhosis- Child's class C liver disease Have seizure disorder requiring anticonvulsant History of allergy or intolerance to the study product components Receiving glutamine during two weeks before start study product Have other reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamin<br>Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs. | Drug: Glutamin<br>* Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.<br>* Other names: L-glutamine;|
| Placebo Comparator: maltodextrin<br>Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs. | Other: Maltodextrin<br>* Maltodextrin mixed with water given via NG tube q 4 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal complication | abdominal distention, vomiting, diarrhea and constipation | Day10 | 
| Mortality in ICU | Mortality rate in ICU | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral Nutrition, Glutamin, Intensive Care Unit, Intestinal Permeability