Probiotic Enteral Administration in Mechanically Ventilated Patients
Primary Purpose
Pneumonia
Status
Terminated
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Ergyphilus
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring ventilator-associated pneumonia, probiotic, mechanical ventilation, intensive care
Eligibility Criteria
Inclusion Criteria: Patients under mechanical ventilation for at least 48 hours Exclusion Criteria: Age under 18 Pregnancy Immunocompromised status Short bowel disease Moribund condition
Sites / Locations
- CHG
- CHR
- Hopital Central, Service de Reanimation Medicale
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Intensive Care Unit (ICU) mortality rate
Secondary Outcome Measures
Hospital mortality rate
incidence of ventilator-associated pneumonia
incidence of multi-resistant bacteria infection and colonization
incidence of diarrhea
ICU length of stay
hospital length of stay
antibiotic use in ICU (antibiotic-free days)
Full Information
NCT ID
NCT00122408
First Posted
July 19, 2005
Last Updated
September 23, 2010
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT00122408
Brief Title
Probiotic Enteral Administration in Mechanically Ventilated Patients
Official Title
Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients: Double-Blind, Prospective Randomized Study Versus Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
5. Study Description
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.
Detailed Description
In a critically ill patient, the gut integrity is rapidly compromised either by the treatments used (such as catecholamine or antibiotics) or by the disease itself. This gut alteration favours the adhesion and/or internalisation of bacteria by intestine cells which lead to the production of large amounts of cytokines that rapidly reach the blood compartment, inducing neutrophils activation and then organ damage. Moreover, the imbalance in the normal intestinal flora (demonstrated as early as 24 hours after ICU admission) is one of the mechanisms involved in the development of ventilator associated pneumonia (VAP). VAP is the leading cause of ICU-acquired infection and is responsible for prolonged ICU stay, increased mortality and costs. Probiotics, and especially Lactobacillus Rhamnosus GG ('LGG'), have been demonstrated to possess beneficial effects in terms of intestine flora imbalance and immune response.
Objective: To study the effects of a probiotic mixture (containing LGG) enteral administration on the survival and the incidence of VAP in mechanically ventilated patients.
Patients and Methods: Prospective, randomized, double-blind, placebo-controlled study. After randomization, 740 intubated patients with a predictive length of mechanical support of more than 48 hours will enterally receive either 10.10 cfu of probiotic (Ergyphilus, Nutergia, France) or a identical placebo daily until withdrawal of mechanical support. The main endpoint is the mortality rate in ICU. Secondary endpoints include hospital length of stay and mortality rate, VAP incidence and the number of days free from antibiotics. Length of the study 24 months.
Perspectives: The objective is to demonstrate a survival advantage due to LGG administration, along with a reduction of VAP episodes and antibiotic use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
ventilator-associated pneumonia, probiotic, mechanical ventilation, intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
740 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ergyphilus
Intervention Description
5 pills a day of Ergyphilus or placebo
Primary Outcome Measure Information:
Title
Intensive Care Unit (ICU) mortality rate
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Hospital mortality rate
Time Frame
60 days
Title
incidence of ventilator-associated pneumonia
Time Frame
28 days
Title
incidence of multi-resistant bacteria infection and colonization
Time Frame
28 days
Title
incidence of diarrhea
Time Frame
28 days
Title
ICU length of stay
Time Frame
60 days
Title
hospital length of stay
Time Frame
60 days
Title
antibiotic use in ICU (antibiotic-free days)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients under mechanical ventilation for at least 48 hours
Exclusion Criteria:
Age under 18
Pregnancy
Immunocompromised status
Short bowel disease
Moribund condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Gibot, MD, PhD
Organizational Affiliation
CHU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHG
City
Macon
Country
France
Facility Name
CHR
City
Metz
Country
France
Facility Name
Hopital Central, Service de Reanimation Medicale
City
Nancy
ZIP/Postal Code
54000
Country
France
12. IPD Sharing Statement
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Probiotic Enteral Administration in Mechanically Ventilated Patients
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