Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial

Completed · Phase 4 · Has a placebo group

Conditions studied: Ventilator Associated Pneumonia, Infections, C-Difficile, Antibiotic-associated Diarrhea, Diarrhea

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 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.

Key facts

Study ID

NCT02462590

Run by

McMaster University

People needed

2650

Starts

2015-06-01

Expected to finish

2020-11-17

Last updated by the study team

2020-12-17

Who can join

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

You may qualify if…

• Adults ≥ 18 years of age
• Admitted to any ICU and receiving invasive mechanical ventilation
• Anticipated ventilation of ≥72 hours at the time of screening, as per the ICU physician.

You may not qualify if…

• Invasively mechanically ventilated >72 hours at the time of screening;
• Patients at potential increased risk of iatrogenic probiotic infection (see Section 2.6 for detailed explanation) including specific immunocompromised populations (HIV <200 CD4 cells/μL, those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2), previous transplantation (including stem cell) at any time, malignancy requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count < 500]). However, patients receiving corticosteroids previously or presently or projected to receive corticosteroids are not excluded;
• Patients at risk for endovascular infection (previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material [mechanical or bio-prosthetic cardiac valves], previous or current endocarditis, permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids], inferior vena cava filters, dialysis vascular grafts), tunnelled (not short-term) hemodialysis catheters, pacemakers or defibrillators. Patients with temporary central venous catheters, central venous dialysis catheters or peripherally inserted central catheters (PICCs) are not excluded and patients with coronary artery stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded; patients with mitral valve prolapse or bicuspid aortic valve are not excluded providing they have no other exclusion criteria;
• Patients with a primary diagnosis of severe acute pancreatitis, without reference to a Ranson score [Ranson 1974]). However, patients with mild or moderate pancreatitis are not excluded;
• Patients with percutaneous gastric or jejunal feeding tubes already in situ as per Health Canada guidance;
• Strict contraindication or inability to receive enteral medications;
• Intent to withdraw advanced life support as per the ICU physician;
• Previous enrolment in this or current enrolment in a potentially confounding tria

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• St. John's Mercy Medical Center — St Louis, Missouri, United States
• Peter Louheed Center — Calgary, Alberta, Canada
• Foothills Medical Center — Calgary, Alberta, Canada
• Univeristy of Alberta — Edmonton, Alberta, Canada
• Royal Columbia Hospital — New Westminster, British Columbia, Canada
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• Vancouver Island Health Authority — Vancouver, British Columbia, Canada
• Health Science - Winnipeg — Winnipeg, Manatoba, Canada
• St. Boniface — Winnipeg, Manitoba, Canada
• QEII — Halfax, Nova Scotia, Canada
• William Osler Brampton - Brampton Civic Hospital — Brampton, Ontario, Canada
• Brantford General Hospital — Brantford, Ontario, Canada
• Joseph Brant Hospital — Burlington, Ontario, Canada
• Royal Alexandra Hospital — Edmonton, Ontario, Canada
• Hamilton Health Science Centre - Hamilton General Hospital — Hamilton, Ontario, Canada
• St Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Hamilton Health Science Centre - Juravinski Hospital — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• Grand River Hospital — Kitchener, Ontario, Canada
• LHSC - University Hospital — London, Ontario, Canada
• LHSC - Victoria Hospital — London, Ontario, Canada
• Ottawa General Hospital — Ottawa, Ontario, Canada
• Ottawa Civic Hospital — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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