Skip to content

Enteral Glutamine in Neurologically-injured Patients

Randomized, Placebo-controlled Clinical Trial of Enteral Glutamine Supplementation in Neurologically-injured Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00204971
Enrollment
102
Registered
2005-09-20
Start date
2003-01-31
Completion date
2008-01-31
Last updated
2015-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Injury, Traumatic Brain Injury

Brief summary

Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients.The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.

Interventions

DIETARY_SUPPLEMENTEnteral glutamine powder

nutritional supplement

OTHERplacebo

placebo control

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Males * Nonpregnant females * Aged 18-75 years old * Glasgow Coma Scores of 3-12 * Injury Severity Scores greater than or equal to 20 * Requiring enteral nutrition for a minimum of 5 days

Exclusion criteria

* Documented hepatic dysfunction * Acute renal failure (creatinine clearance \< 15 mL/min) * Gastrointestinal malabsorptive disorder * Infection at time of admission

Design outcomes

Primary

MeasureTime frame
Nosocomial infectionsthroughout study

Secondary

MeasureTime frame
Multiple organ dysfunction syndromethroughout the study
Nutritional outcome parametersthroughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026