NCT00122408

Brief Summary

The objective of this study is to assess the effects of a daily enteral supplementation with probiotics within a population of critically ill, mechanically ventilated patients. Especially, the effects of probiotics on mortality rate in intensive care medicine will be analysed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
740

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

July 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

September 24, 2010

Status Verified

September 1, 2010

Enrollment Period

3.6 years

First QC Date

July 19, 2005

Last Update Submit

September 23, 2010

Conditions

Pneumonia

Keywords

ventilator-associated pneumoniaprobioticmechanical ventilationintensive care

Outcome Measures

Primary Outcomes (1)

  • Intensive Care Unit (ICU) mortality rate

    28 days

Secondary Outcomes (7)

  • Hospital mortality rate

    60 days

  • incidence of ventilator-associated pneumonia

    28 days

  • incidence of multi-resistant bacteria infection and colonization

    28 days

  • incidence of diarrhea

    28 days

  • ICU length of stay

    60 days

  • +2 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR
Dietary Supplement: Ergyphilus

2

PLACEBO COMPARATOR
Dietary Supplement: Ergyphilus

Interventions

ErgyphilusDIETARY_SUPPLEMENT

5 pills a day of Ergyphilus or placebo

12

Eligibility Criteria

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

You may qualify if:

  • Patients under mechanical ventilation for at least 48 hours

You may not qualify if:

  • Age under 18
  • Pregnancy
  • Immunocompromised status
  • Short bowel disease
  • Moribund condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHG

Mâcon, France

Location

CHR

Metz, France

Location

Hopital Central, Service de Reanimation Medicale

Nancy, 54000, France

Location

MeSH Terms

Conditions

PneumoniaPneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesHealthcare-Associated PneumoniaCross InfectionIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sebastien Gibot, MD, PhD

    CHU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
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

July 19, 2005

First Posted

July 22, 2005

Study Start

January 1, 2006

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

September 24, 2010

Record last verified: 2010-09

Locations

FR(3)