NCT03113240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

April 10, 2017

Last Update Submit

April 8, 2018

Conditions

Critical IllnessEnteral NutritionIntestinal Permeability

Keywords

GlutaminEnteral NutritionIntensive Care UnitIntestinal Permeability

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Gastrointestinal complication

    Day10

  • Mortality in ICU

    Day 10

  • Length of stay in ICU

    Day 10

  • Severe sepsis

    Day 10

Other Outcomes (1)

  • Serum Glutamin

    baseline, Day 5, Day 10

Study Arms (2)

Glutamin

EXPERIMENTAL

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

Drug: Glutamin

maltodextrin

PLACEBO COMPARATOR

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

Other: Maltodextrin

Interventions

GlutaminDRUG

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

Also known as: L-glutamine
Glutamin
MaltodextrinOTHER

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

maltodextrin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tehran, Iran

Location

Related Publications (5)

  • 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.

    PMID: 25810794BACKGROUND

  • 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.

    PMID: 20631386BACKGROUND

  • 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.

    PMID: 26773077BACKGROUND

  • 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.

    PMID: 16697087BACKGROUND

  • 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.

    PMID: 15340021BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

glutamin-(asparagin-)aseGlutaminemaltodextrin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Zahra Vahdat Shariatpanahi, MD, PhD

    Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

April 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

IR(1)