CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,650 target
Drug / intervention
L. rhamnosus GG - Probiotic +1 moredrug
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/NCT02462590
NCT02462590Phase 4Completed

Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)

McMaster University·interventional·Posted Jun 4, 2015·Updated Dec 17, 2020

In Brief

A Phase 4 clinical trial evaluating L. rhamnosus GG - Probiotic and Placebo - Microcrystalline Cellulose for Ventilator Associated Pneumonia and 4 related conditions. Completed, enrolled 2,650 participants across 44 sites in 3 countries.

Detailed Summary

Probiotics are commercially available live bacteria thought to have health benefits when ingested. A literature review of probiotic studies in the intensive care unit (ICU) found that in patients who receive probiotics, there is a 25% reduction in lung infection, known as ventilator-associated pneumonia (VAP). There is also an 18% reduction in the chance of developing any infection in the ICU. However, the studies reviewed were small and not well done. Therefore, whether probiotics are really helpful or not is unclear. Before a large carefully performed study is done to evaluate the effects of probiotics in critically ill patients, a pilot trial was needed. The Investigators completed a multicenter pilot RCT for which the primary outcomes relate to feasibility. Feasibility goals were met. 1) Recruitment for the Pilot was achieved in 1 year; 2) Adherence to the protocol was 96%; 3) There were no cases of contamination; 4) The VAP rate was 15%. This study is very important in the ongoing search for more effective strategies to prevent serious infection during critical illness. Probiotics may be an easy-to-use, readily available, inexpensive approach to help future critically ill patients around the world.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Saudi Arabia, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartJun 1, 2015
Primary CompletionMar 13, 2019
Study CompletionNov 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.1 years ago

Interventions

L. rhamnosus GG - Probioticdrug

Twice daily, patients will receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule

Placebo - Microcrystalline Cellulosedrug

Microcrystalline Cellulose