Probiotic Enteral Administration in Mechanically Ventilated Patients

This study has been terminated.
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00122408
First received: July 19, 2005
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Pneumonia
Dietary Supplement: Ergyphilus
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients: Double-Blind, Prospective Randomized Study Versus Placebo

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Intensive Care Unit (ICU) mortality rate [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital mortality rate [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • incidence of ventilator-associated pneumonia [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • incidence of multi-resistant bacteria infection and colonization [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • incidence of diarrhea [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • hospital length of stay [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • antibiotic use in ICU (antibiotic-free days) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 740
Study Start Date: January 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Dietary Supplement: Ergyphilus
5 pills a day of Ergyphilus or placebo
Placebo Comparator: 2 Dietary Supplement: Ergyphilus
5 pills a day of Ergyphilus or placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00122408

Locations
France
CHG
Macon, France
CHR
Metz, France
Hopital Central, Service de Reanimation Medicale
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: Sebastien Gibot, MD, PhD CHU Nancy
  More Information

No publications provided

Responsible Party: Mr P Boulanger / Directeur de la Recherche et de l'innovation, CHU Nancy
ClinicalTrials.gov Identifier: NCT00122408     History of Changes
Other Study ID Numbers: promotion_070605-gibot_DRI
Study First Received: July 19, 2005
Last Updated: September 23, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
ventilator-associated pneumonia
probiotic
mechanical ventilation
intensive care

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014