Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 224 for:    Intestinal | maltodextrin

A Trial of Enteral Colostrum on Intestinal Permeability in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186716
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ghazaleh Eslamian, National Nutrition and Food Technology Institute

Brief Summary:
The effects of colostrum on intestinal permeability in critical ill patients has not been investigated. In current trial, intensive care unit patients with enteral feeding will receive either enteral colostrum or maltodextrin as placebo.

Condition or disease Intervention/treatment Phase
Critical Illness Dietary Supplement: Colostrum Dietary Supplement: Maltodextrin Not Applicable

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. Intervention patients will be received 20 g/day of colostrum along with enteral formula and control patients will be received maltodextrin along with enteral formula. Patients will be evaluated for plasma endotoxin and plasma zonulin.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Colostrum Supplement on Intestinal Permeability in Hospitalized Patients With Enteral Feeding in Intensive Care Unit
Actual Study Start Date : June 11, 2017
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : March 11, 2018

Arm Intervention/treatment
Experimental: Colostrum
Intervention patients will be received enteral formula and colostrum powder 20 g/kg/day given via nasogastric tube as boluses q 4hrs.
Dietary Supplement: Colostrum
Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
Other Name: Bovine Colostrum

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




Primary Outcome Measures :
  1. Change from Baseline plasma endotoxin concentration at 10 days [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of plasma endotoxin

  2. Change from Baseline plasma zonulin concentration at 10 days [ Time Frame: baseline, Day 5, Day 10 ]
    The levels of plasma zonulin


Secondary Outcome Measures :
  1. Gastrointestinal complications [ Time Frame: Day 10 ]
    abdominal distention, vomiting, diarrhea and constipation

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

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

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 moribund
  • History of allergy or intolerance to the study product components
  • Receiving colostrum 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): NCT03186716


Locations
Layout table for location information
Iran, Islamic Republic of
National Nutrition and Food Technology Research Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
Layout table for investigator information
Principal Investigator: Ghazaleh Eslamian, MS,PhDcandid National Nutrition and Food Technology Research Institute Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ghazaleh Eslamian, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03186716     History of Changes
Other Study ID Numbers: 2017670
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghazaleh Eslamian, National Nutrition and Food Technology Institute:
Colostrum
Enteral Nutrition
Intestinal Permeability
Intensive Care Unit
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes