Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Enteral Nutrition; Intestinal Permeability
• Intervention / Treatment: Drug: Glutamin; Other: Maltodextrin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glutamin; Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.	Drug: Glutamin; 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
PLACEBO_COMPARATOR: maltodextrin; Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.	Other: Maltodextrin; Maltodextrin mixed with water given via NG tube q 4 hours.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Glutamin	The levels of serum Glutamin	baseline, Day 5, Day 10

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Investigators: Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD, Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications and helpful links

General Publications

• 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. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (ACTUAL): April 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 8, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Enteral Nutrition; Intestinal Permeability; Glutamin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 311/4114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No