NCT00220519

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 7, 2008

Status Verified

September 1, 2005

Enrollment Period

7 months

First QC Date

September 14, 2005

Last Update Submit

December 21, 2007

Conditions

Burns

Outcome Measures

Primary Outcomes (2)

  • Infection

    Daily

  • Diarrhea

    Daily

Interventions

Lactobacillus GGDRUG

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • \< 20% total body surface area burn
  • Does not require antibiotic therapy
  • Only requires post-operative antibiotic therapy
  • Bowel obstruction
  • Milk allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children

Boston, Massachusetts, 021114, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Maggie L Dylewski, MS,RD

    Shriners Hospitals for Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

January 7, 2008

Record last verified: 2005-09

Locations

US(1)