Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial

Completed · Phase 2 · Has a placebo group

Conditions studied: Ventilator Associated Pneumonia (VAP), Other Infections, Antibiotic-Associated Diarrhea, C-Difficile, Duration of Mechanical Ventilation, Length of ICU Stay, Length of Hospital Stay, ICU and Hospital Mortality

In brief

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 patients around the world.

Key facts

Study ID: NCT01782755
Run by: McMaster University
People needed: 150
Starts: 2013-10-01
Expected to finish: 2015-01-01
Last updated by the study team: 2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults ≥18 years old in the ICU;
Mechanically ventilated with anticipated ventilation of ≥72 hours at enrolment.

You may not qualify if…

Mechanical ventilation exceeding 72 hours at time of screening.
Increased risk of iatrogenic probiotic infection including specific immunocompromised populations (HIV <200 CD4 cells/μL, chronic immunosuppressive medications, prior organ or hematological transplant, neutropenia (absolute neutrophil count <500).
Increased risk for endovascular infection (history of rheumatic heart disease, congenital heart defect, mechanical valves, endocarditis, endovascular grafts, permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers or defibrillators).
Mucosal gastrointestinal tract defects (gastroesophageal or intestinal injury, including active bleeding), surgery of the esophagus, stomach, small or large bowel, liver, gallbladder, hepatobiliary tree, spleen, or pancreas within 72 hours, suspected or documented ischemic gut and severe acute pancreatitis.
Strict contraindication or inability to receive enteral medications.
Pregnancy.
Intent to withdraw advanced life support.
Enrolment in this or an ongoing related trial.

Where it is running

Mayo Clinic — Rochester, Minnesota, United States
St. John's Mercy Medical Center — St Louis, Missouri, United States
Vancouver General Hospital — Vancouver, British Columbia, Canada
St. Paul's Hospital — Vancouver, British Columbia, Canada
Vancouver Island Health Authority — Victoria, British Columbia, Canada
Hamilton Health Science - Hamilton General Hospital — Hamilton, Ontario, Canada
St Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
Hamilton Health Science - Juravinski Hospital — Hamilton, Ontario, Canada
Ottawa Hospital Research Institute - Civic Campus — Ottawa, Ontario, Canada
Ottawa Research Institute - General Hospital — Ottawa, Ontario, Canada
St Michael's Hospital — Toronto, Ontario, Canada
Mount Sinai Hospital — Toronto, Ontario, Canada
University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada
Hopital de l'Enfant Jesus — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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