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
Pneumonia	Drug: Ergyphilus

Further Study Details: 

Primary Outcomes: ICU Mortality rate
Secondary Outcomes: 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)
Expected Total Enrollment:  740

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 (Ergyphillus, 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00122408

Sebastien Gibot, MD, PhD      +33383852970    s.gibot@chu-nancy.fr

France
      Hopital Central, Service de Reanimation Medicale, Nancy,  54000,  France

Study chairs or principal investigators

Sebastien Gibot, MD, PhD,  Principal Investigator,  CHU Nancy   

Study ID Numbers:  promotion_070605-gibot_DRI
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122408
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-07-26