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NCT02462590 · ClinicalTrials.gov registry record · Phase 4
Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial
A Phase 4 study, sponsored by McMaster University.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,650
- Enrollment target
NCT02462590 is a Phase 4 study that has completed, run by McMaster University. The registered enrollment target is 2,650 participants.
The verdict
NCT02462590, a Phase 4 study, has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,650 participants
- Enrollment target
Study 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.
Interventions
- DRUG L. rhamnosus GG - Probiotic
- DRUG Placebo - Microcrystalline Cellulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,650 participants |
| Start Date | 2015-06 |
| Est. Completion | 2020-11-17 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02462590
The ClinicalTrials.gov registry entry for NCT02462590 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which L. rhamnosus GG - Probiotic is the first listed.
NCT02462590 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02462590 about?
NCT02462590 is a clinical study titled "Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial". 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 pneum...
What is the current status of trial NCT02462590?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,650 participants. The study started on 2015-06. Estimated completion is 2020-11-17.
What interventions are being tested in trial NCT02462590?
The interventions under investigation include: L. rhamnosus GG - Probiotic (DRUG), Placebo - Microcrystalline Cellulose (DRUG).
Who is sponsoring clinical trial NCT02462590?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
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