Skip to main content
OpenTrials
Completed

NCT Number: NCT03113240

Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamin

Drug

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

Other

Maltodextrin mixed with water given via NG tube q 4 hours.

Primary outcomes

  1. Maximum plasma endotoxin concentration

    Time frame: baseline, Day 5, Day 10

    The levels of plasma endotoxin

  2. Maximum plasma zonulin concentration

    Time frame: baseline, Day 5, Day 10

    The levels of plasma zonulin

  3. Maximum plasma antiendotoxin IgG and Ig M concentration

    Time frame: baseline, Day 5, Day 10

    The levels of plasma antiendotoxin IgG and Ig M concentration

Secondary outcomes

  1. Gastrointestinal complication

    Time frame: Day10

    abdominal distention, vomiting, diarrhea and constipation

  2. Mortality in ICU

    Time frame: Day 10

    Mortality rate in ICU

  3. Length of stay in ICU

    Time frame: Day 10

    Duration of stay in ICU

  4. Severe sepsis

    Time frame: Day 10

    according to the American College of Chest Physicians and the Society of Critical Care Medicine

Other outcomes

  1. Serum Glutamin

    Time frame: baseline, Day 5, Day 10

    The levels of serum Glutamin

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2017
Registry last updated
Apr 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.