Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113240
• Other study ID #: 311/4114
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2017
• Last updated: April 8, 2018
• Start date: April 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: April 2018
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition
• Intestinal Permeability

Intervention

Drug:
• Glutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (5)

D'Souza R, Powell-Tuck J. Glutamine supplements in the critically ill. J R Soc Med. 2004 Sep;97(9):425-7. Review. — View Citation

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. — View Citation

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. Epub 2006 May 11. — View Citation

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. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Glutamin	The levels of serum Glutamin	baseline, Day 5, Day 10
Primary	Maximum plasma endotoxin concentration	The levels of plasma endotoxin	baseline, Day 5, Day 10
Primary	Maximum plasma zonulin concentration	The levels of plasma zonulin	baseline, Day 5, Day 10
Primary	Maximum plasma antiendotoxin IgG and Ig M concentration	The levels of plasma antiendotoxin IgG and Ig M concentration	baseline, Day 5, Day 10
Secondary	Gastrointestinal complication	abdominal distention, vomiting, diarrhea and constipation	Day10
Secondary	Mortality in ICU	Mortality rate in ICU	Day 10
Secondary	Length of stay in ICU	Duration of stay in ICU	Day 10
Secondary	Severe sepsis	according to the American College of Chest Physicians and the Society of Critical Care Medicine	Day 10