Lactobacillus GG Supplementation During Pediatric Burn Injuries

This study has been terminated.
(Study stopped due to low enrollment)
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00220519
First received: September 14, 2005
Last updated: December 21, 2007
Last verified: September 2005
  Purpose

Critical illness and the therapies that accompany it are associated with a disruption in the ecological equilibrium of the GI tract that can ultimately lead to infection. Lactobacillus GG, a probiotic, replenishes the healthy flora of the intestinal tract and may decrease the risk of diarrhea and infection during critical illness. However, little is known about the impact of probiotics following a burn injury and the mechanisms behind the proposed benefits. The hypothesis of this research is that Lactobacillus GG decreases the incidence of diarrhea and infection in burned children receiving antibiotic therapy. The specific aim of this research is to determine the impact of Lactobacillus GG on the incidence of diarrhea and infection among burned children (>20% TBSA) receiving antibiotic therapy.


Condition Intervention
Burns
Drug: Lactobacillus GG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lactobacillus GG Supplementation During Pediatric Burn Injuries

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Infection [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Diarrhea [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: October 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:

Specific Aim:

Critical illness and the therapies that accompany it are associated with a disruption in the ecological equilibrium of the GI tract that can ultimately lead to infection. Lactobacillus GG, a probiotic, repletes the healthy flora of the intestinal tract and may decrease the risk of diarrhea and infection during critical illness. However, little is known about the impact of probiotics following a burn injury and the mechanisms behind the proposed benefits. The hypothesis of this research is that Lactobacillus GG decreases the incidence of diarrhea and infection in burned children receiving antibiotic therapy. The specific aim of this research is to determine the impact of Lactobacillus GG on the incidence of diarrhea and infection among burned children (>20% TBSA) receiving antibiotic therapy.

Subjects:

All subjects will be recruited from the Shriners Hospitals for Children in Boston. Patients of any age admitted to Shriners Hospitals for Children in Boston that match the following inclusion criteria will be considered for this study 1)burn wound size of at least 20% of the body surface area, 2)requires antibiotic therapy. Exclusion criteria includes: 1) < 20% total body surface area burn, 2)does not require antibiotic therapy, 3)only requires post-operative antibiotic therapy, 4)bowel obstruction, 5)milk allergy.

Study Design:

This is a randomized, double-blind, placebo-controlled trial. Patients will be randomly assigned to receive Lactobacillus GG (n = 47) or a placebo (n = 47) within 3 days of initiation of antibiotic therapy. Randomization will occur by using a computerized randomization list. A pharmacist, who is not a member of the study staff, will assign each of the 2 supplement groups a number and label the supplement bottles accordingly.

Methods:

Lactobacillus GG, a nonpathogenic microorganism, will be administered in this study. A dose of 1010 colony factor units (cfu) twice daily will be given to the experimental group (n =47). The control group will receive a placebo (n = 47) that will be identical in appearance to the probiotic. All supplements will be administered orally or via feeding tube. The study endpoint will be 10 days after antibiotic use is discontinued or patient discharge Parameters measured will include 1) the occurrence of pneumonia or infection in the wound, blood, or urine, as defined by The National Nosocomial Infection Surveillance System (A localized or systemic condition that results from adverse reaction to the presence of an infectious agent(s) or toxin(s)) and clarified by the Infection Control Nurse, 2) incidence of diarrhea defined as 3 or more loose or watery stools per 24 hours, 3) weekly weights and labs (including total protein, albumin, prealbumin and C-reactive protein) as obtained per routine care, 4) length of antibiotic use, 5) length of stay.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Burn wound size of at least 20% of the body surface area
  • Requires antibiotic therapy

Exclusion Criteria:

  • < 20% total body surface area burn
  • Does not require antibiotic therapy
  • Only requires post-operative antibiotic therapy
  • Bowel obstruction
  • Milk allergy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220519

Locations
United States, Massachusetts
Shriners Hospitals for Children
Boston, Massachusetts, United States, 021114
Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: Maggie L Dylewski, MS,RD Shriners Hospitals for Children
  More Information

No publications provided

Responsible Party: Maggie L. Dylewski, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT00220519     History of Changes
Other Study ID Numbers: 2004-P-001990/1
Study First Received: September 14, 2005
Last Updated: December 21, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014