Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

Shahid Beheshti University

Status and phase: Completed; Phase 3

Conditions: Intestinal Permeability; Enteral Nutrition; Critical Illness

Treatments: Other: Maltodextrin; Drug: Glutamin

Study type: Interventional

Funder types: Other

Identifiers

NCT03113240

311/4114

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Glutamin

Experimental group

Description:

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

Treatment:

Drug: Glutamin

maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Other: Maltodextrin