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Probiotic Enteral Administration in Mechanically Ventilated Patients

NCT ID: NCT00122408

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Ergyphilus

Intervention Type DIETARY_SUPPLEMENT

5 pills a day of Ergyphilus or placebo

2

Group Type PLACEBO_COMPARATOR

Ergyphilus

Intervention Type DIETARY_SUPPLEMENT

5 pills a day of Ergyphilus or placebo

Interventions

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Ergyphilus

5 pills a day of Ergyphilus or placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients under mechanical ventilation for at least 48 hours

Exclusion Criteria

* Age under 18
* Pregnancy
* Immunocompromised status
* Short bowel disease
* Moribund condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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CHU Nancy

Principal Investigators

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Sebastien Gibot, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU NANCY

Locations

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CHG

Mâcon, , France

Site Status

CHR

Metz, , France

Site Status

Hopital Central, Service de Reanimation Medicale

Nancy, , France

Site Status

Countries

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France

Other Identifiers

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promotion_070605-gibot_DRI

Identifier Type: -

Identifier Source: org_study_id