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NCT01782755 · ClinicalTrials.gov registry record · Phase 2
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial
A Phase 2 study, sponsored by McMaster University.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT01782755 is a Phase 2 study that has completed, run by McMaster University. The registered enrollment target is 150 participants.
The verdict
NCT01782755, a Phase 2 study, has completed, sponsored by McMaster University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 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 is needed. The investigators plan to study the feasibility of such a trial in mechanically ventilated ICU patients in 11 ICUs in Ontario, investigating whether orally ingested L. rhamnosus GG (a common probiotic) prevents VAP and other infections. The 4 goals of the pilot study will be to ensure that we can successfully enrol patients; follow the protocol faithfully; make sure patients don't receive additional probiotics, and estimate how much pneumonia exists in these patients. In a separate substudy, the investigators will evaluate the effects of probiotics on lower lung infiltration with potential harmful bacteria, stool bacteria, markers of immunity called cytokines, and markers of infection called endotoxin levels. The investigators plan to enroll 150 adults admitted to ICU and receiving mechanical ventilation. Following informed consent, patients will be randomized to either L. rhamnosus GG group or an identical placebo. Twice daily, patients will receive probiotics or placebo in a feeding tube. The investigators will record all infections and other important outcomes in the ICU. 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 pati
Interventions
- DRUG L. rhamnosus GG - Probiotic
- OTHER Placebo - Microcrystalline Cellulose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01782755
The ClinicalTrials.gov registry entry for NCT01782755 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 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.
NCT01782755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01782755 about?
NCT01782755 is a clinical study titled "Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical 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 NCT01782755?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2013-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01782755?
The interventions under investigation include: L. rhamnosus GG - Probiotic (DRUG), Placebo - Microcrystalline Cellulose (OTHER).
Who is sponsoring clinical trial NCT01782755?
This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.
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