CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
LactoLevure +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03074552
NCT03074552N/ACompleted

Probiotic Prophylaxis for Microbiome Modulation and Ventilator Associated Pneumonia (VAP) or Severe Infections Prevention in Multitrauma Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Aristotle University Of Thessaloniki·interventional·Posted Mar 9, 2017·Updated Aug 31, 2021

In Brief

A clinical study evaluating LactoLevure and Placebo for Ventilator Associated Pneumonia and 2 related conditions. Completed, enrolled 112 participants across 1 site.

Detailed Summary

Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48 hours after endotracheal intubation, is common in intensive care units (ICUs). It is estimated to be responsible for 27% to 47% of ICU-acquired infections. The pathogenesis of VAP is complex but typically involves colonization of the aerodigestive tract with pathogenic bacteria, the formation of biofilms, and microaspiration of contaminated secretions. Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of VAP. One novel intervention is the administration of prophylactic probiotics which restore non-pathogenic flora that compete with pathogens, modulate local and systemic immunity, and decrease intestinal permeability and thus can be beneficial in preventing nosocomial infections in critically ill patients. The role of the probiotics in preventing VAP in mechanically ventilated patients is inconclusive. Some evidence indicates that probiotics may reduce the incidence of VAP by inhibiting pathogen adhesion, improving gut mucosal barrier function, reducing bacterial translocation and up-regulating the immune system. Furthermore, guidelines remain inconclusive regarding the role of commensal oropharyngeal flora (COF) as a causative agent in VAP, mainly due to a scarcity of studies in this research field. However, there is evidence that COF may cause pulmonary infection, mostly in immunocompromised patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
CollaboratorsUni-Pharma

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 9, 2017
Enrollment StartAug 19, 2017
Primary CompletionNov 15, 2020
Study CompletionDec 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.3 years ago

Interventions

LactoLevuredietary

The probiotic preparation will consist a combination of four probiotics: Lactobacillus acidophilus LA-5 1.75 × 109 CFU, Lactobacillus Plantarum 0.5 × 109 CFU, Bifidobacterium lactis BB-12 1.75 × 109 CFU και Saccharomyces boulardii 1.5 × 109 CFU per capsule (LactoLevure, UniPharma, Athens, Greece).

Placeboother

Placebo will consist of identical capsules of powdered glucose polymer