Probiotic Enteral Administration in Mechanically Ventilated Patients

Phase 1

Terminated

• Conditions: Pneumonia
• Interventions: Dietary Supplement: Ergyphilus

• Registration Number: NCT00122408
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2005-07-19
• Study First Submitted QC: 2005-07-19
• Study First Posted: 2005-07-22
• Study Start: 2006-01
• Primary Completion: 2009-08
• Study Completion: 2009-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

• Patients under mechanical ventilation for at least 48 hours

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Ergyphilus	-
1	Ergyphilus	-

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit (ICU) mortality rate	28 days

Secondary Outcome Measures

Name	Time	Method
hospital length of stay	60 days
incidence of ventilator-associated pneumonia	28 days
Hospital mortality rate	60 days
incidence of multi-resistant bacteria infection and colonization	28 days
incidence of diarrhea	28 days
ICU length of stay	60 days
antibiotic use in ICU (antibiotic-free days)	28 days

Trial Locations

Locations (3)

CHR; 🇫🇷 Metz, France

CHG; 🇫🇷 Macon, France

Hopital Central, Service de Reanimation Medicale; 🇫🇷 Nancy, France