Clinical trial NCT03113240: Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients
Official title: Effects of Enteral Glutamine on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Illness
Enteral Nutrition
Intestinal Permeability
Keywords: Glutamin
Enteral Nutrition
Intensive Care Unit
Intestinal Permeability
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma endotoxin concentration
timeFrame: baseline, Day 5, Day 10
measure: Maximum plasma zonulin concentration
timeFrame: baseline, Day 5, Day 10
measure: Maximum plasma antiendotoxin IgG and Ig M concentration
timeFrame: baseline, Day 5, Day 10
Secondary outcomes:
measure: Gastrointestinal complication
timeFrame: Day10
measure: Mortality in ICU
timeFrame: Day 10
measure: Length of stay in ICU
timeFrame: Day 10
measure: Severe sepsis
timeFrame: Day 10
Other outcomes:
measure: Serum Glutamin
timeFrame: baseline, Day 5, Day 10
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Study officials:
affiliation: Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
name: Zahra Vahdat Shariatpanahi, MD, PhD
role: STUDY_CHAIR
References:
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. doi: 10.2174/1875044301205010047. No abstract available.
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.
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. No abstract available.
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. doi: 10.1016/j.clnu.2006.01.021. Epub 2006 May 11.
citation: 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.