NCT00621803

Brief Summary

Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2003

Typical duration for not_applicable

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

March 1, 2003

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

February 22, 2008

Status Verified

February 1, 2008

Enrollment Period

1.6 years

First QC Date

February 11, 2008

Last Update Submit

February 21, 2008

Conditions

Pseudomonas Infections

Keywords

ProbioticPseudomonas aeruginosaGastric colonizationRespiratory tract colonizationVentilator aquired pneumoniaedetermine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa

Outcome Measures

Primary Outcomes (1)

  • Delay in P.aeruginosa colonisation

Secondary Outcomes (1)

  • Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach

Interventions

Probiotic Lactobacillus casei rhamnosus (Lcr35)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 years old
  • length of stay longer than 48h
  • with a nasogastric feeding tube

You may not qualify if:

  • \- less than 18 years old
  • length of stay \< 48h
  • immunosuppression
  • absolute neutrophile count \< 500/mm3
  • gastro-intestinal bleeding
  • contraindicated enteral feeding
  • positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pseudomonas Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Christophe De Champs, MD PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

March 1, 2003

Primary Completion

October 1, 2004

Study Completion

October 1, 2005

Last Updated

February 22, 2008

Record last verified: 2008-02