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Trial record 19 of 592 for:    maltodextrin

Trial of Enteral Glutamine on Intestinal Permeability in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03113240
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Vahdat Shariatpanahi, Shahid Beheshti University

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.

Condition or disease Intervention/treatment Phase
Critical Illness Enteral Nutrition Intestinal Permeability Drug: Glutamin Other: Maltodextrin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Enteral Glutamine on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Glutamin
Intervention patients will be received enteral formula and glutamine 0.3 g/kg/day given via nasogastric tube as boluses q 4hrs.
Drug: Glutamin
Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.
Other Name: L-glutamine

Placebo Comparator: maltodextrin
Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
Other: Maltodextrin
Maltodextrin mixed with water given via NG tube q 4 hours.




Primary Outcome Measures :
  1. Maximum plasma endotoxin concentration [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of plasma endotoxin

  2. Maximum plasma zonulin concentration [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of plasma zonulin

  3. Maximum plasma antiendotoxin IgG and Ig M concentration [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of plasma antiendotoxin IgG and Ig M concentration


Secondary Outcome Measures :
  1. Gastrointestinal complication [ Time Frame: Day10 ]
    abdominal distention, vomiting, diarrhea and constipation

  2. Mortality in ICU [ Time Frame: Day 10 ]
    Mortality rate in ICU

  3. Length of stay in ICU [ Time Frame: Day 10 ]
    Duration of stay in ICU

  4. Severe sepsis [ Time Frame: Day 10 ]
    according to the American College of Chest Physicians and the Society of Critical Care Medicine


Other Outcome Measures:
  1. Serum Glutamin [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of serum Glutamin



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113240


Locations
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Iran, Islamic Republic of
Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Shohada Tajrish Hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: Zahra Vahdat Shariatpanahi, MD, PhD Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications:

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Responsible Party: Zahra Vahdat Shariatpanahi, Associate Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT03113240     History of Changes
Other Study ID Numbers: 311/4114
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Zahra Vahdat Shariatpanahi, Shahid Beheshti University:
Glutamin
Enteral Nutrition
Intensive Care Unit
Intestinal Permeability
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes