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Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Primary Purpose

Critical Illness, Enteral Nutrition, Intestinal Permeability

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Glutamin
Maltodextrin
Sponsored by
Shahid Beheshti University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Glutamin, Enteral Nutrition, Intensive Care Unit, Intestinal Permeability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamin

maltodextrin

Arm Description

Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.

Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.

Outcomes

Primary Outcome Measures

Maximum plasma endotoxin concentration
The levels of plasma endotoxin
Maximum plasma zonulin concentration
The levels of plasma zonulin
Maximum plasma antiendotoxin IgG and Ig M concentration
The levels of plasma antiendotoxin IgG and Ig M concentration

Secondary Outcome Measures

Gastrointestinal complication
abdominal distention, vomiting, diarrhea and constipation
Mortality in ICU
Mortality rate in ICU
Length of stay in ICU
Duration of stay in ICU
Severe sepsis
according to the American College of Chest Physicians and the Society of Critical Care Medicine

Full Information

First Posted
April 10, 2017
Last Updated
April 8, 2018
Sponsor
Shahid Beheshti University
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1. Study Identification

Unique Protocol Identification Number
NCT03113240
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Enteral Nutrition, Intestinal Permeability
Keywords
Glutamin, Enteral Nutrition, Intensive Care Unit, Intestinal Permeability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamin
Arm Type
Experimental
Arm Description
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
Arm Title
maltodextrin
Arm Type
Placebo Comparator
Arm Description
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Intervention Type
Drug
Intervention Name(s)
Glutamin
Other Intervention Name(s)
L-glutamine
Intervention Description
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.
Intervention Type
Other
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin mixed with water given via NG tube q 4 hours.
Primary Outcome Measure Information:
Title
Maximum plasma endotoxin concentration
Description
The levels of plasma endotoxin
Time Frame
baseline, Day 5, Day 10
Title
Maximum plasma zonulin concentration
Description
The levels of plasma zonulin
Time Frame
baseline, Day 5, Day 10
Title
Maximum plasma antiendotoxin IgG and Ig M concentration
Description
The levels of plasma antiendotoxin IgG and Ig M concentration
Time Frame
baseline, Day 5, Day 10
Secondary Outcome Measure Information:
Title
Gastrointestinal complication
Description
abdominal distention, vomiting, diarrhea and constipation
Time Frame
Day10
Title
Mortality in ICU
Description
Mortality rate in ICU
Time Frame
Day 10
Title
Length of stay in ICU
Description
Duration of stay in ICU
Time Frame
Day 10
Title
Severe sepsis
Description
according to the American College of Chest Physicians and the Society of Critical Care Medicine
Time Frame
Day 10
Other Pre-specified Outcome Measures:
Title
Serum Glutamin
Description
The levels of serum Glutamin
Time Frame
baseline, Day 5, Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Vahdat Shariatpanahi, MD, PhD
Organizational Affiliation
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25810794
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.
Results Reference
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PubMed Identifier
20631386
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.
Results Reference
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PubMed Identifier
26773077
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. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.
Results Reference
background
PubMed Identifier
16697087
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.
Results Reference
background
PubMed Identifier
15340021
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.
Results Reference
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Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

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