Probiotic Enteral Administration in Mechanically Ventilated Patients

Pneumonia Clinical Trial

Official title:

Effect of Enterally Administered Probiotics in Mechanically Ventilated Patients: Double-Blind, Prospective Randomized Study Versus Placebo

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122408
• Other study ID #: promotion_070605-gibot_DRI
• Status: Terminated
• Phase: Phase 1
• First received: July 19, 2005
• Last updated: September 23, 2010
• Start date: January 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2010
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 740
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

Intervention

Dietary Supplement:
• Ergyphilus
5 pills a day of Ergyphilus or placebo

Locations

Country	Name	City	State
France	CHG	Macon
France	CHR	Metz
France	Hopital Central, Service de Reanimation Medicale	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensive Care Unit (ICU) mortality rate		28 days	No
Secondary	Hospital mortality rate		60 days	No
Secondary	incidence of ventilator-associated pneumonia		28 days	No
Secondary	incidence of multi-resistant bacteria infection and colonization		28 days	No
Secondary	incidence of diarrhea		28 days	No
Secondary	ICU length of stay		60 days	No
Secondary	hospital length of stay		60 days	No
Secondary	antibiotic use in ICU (antibiotic-free days)		28 days	No