Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Tehran, Iran
NCT Number: NCT03113240
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Tehran, Iran
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.
Other names: L-glutamine
Maltodextrin mixed with water given via NG tube q 4 hours.
Time frame: baseline, Day 5, Day 10
The levels of plasma endotoxin
Time frame: baseline, Day 5, Day 10
The levels of plasma zonulin
Time frame: baseline, Day 5, Day 10
The levels of plasma antiendotoxin IgG and Ig M concentration
Time frame: Day10
abdominal distention, vomiting, diarrhea and constipation
Time frame: Day 10
Mortality rate in ICU
Time frame: Day 10
Duration of stay in ICU
Time frame: Day 10
according to the American College of Chest Physicians and the Society of Critical Care Medicine
Time frame: baseline, Day 5, Day 10
The levels of serum Glutamin
Shahid Beheshti University
Other
Effects of Enteral Glutamine on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
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