Antibiotic-Associated Diarrhea Clinical Trial
— PROSPECTOfficial title:
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial
NCT number | NCT01782755 |
Other study ID # | 28012013 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | January 2015 |
Verified date | March 2016 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 2015 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 1. Adults =18 years old in the ICU; 2. Mechanically ventilated with anticipated ventilation of =72 hours at enrolment. Exclusion criteria: 1. Mechanical ventilation exceeding 72 hours at time of screening. 2. 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). 3. 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). 4. 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. 5. Strict contraindication or inability to receive enteral medications. 6. Pregnancy. 7. Intent to withdraw advanced life support. 8. Enrolment in this or an ongoing related trial. |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Science - Hamilton General Hospital | Hamilton | Ontario |
Canada | Hamilton Health Science - Juravinski Hospital | Hamilton | Ontario |
Canada | St Joseph's Healthcare Hamilton | Hamilton | Ontario |
Canada | Ottawa Hospital Research Institute - Civic Campus | Ottawa | Ontario |
Canada | Ottawa Research Institute - General Hospital | Ottawa | Ontario |
Canada | Hopital de l'Enfant Jesus | Quebec City | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | St Michael's Hospital | Toronto | Ontario |
Canada | University Health Network - Toronto Western Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Canada | Vancouver Island Health Authority | Victoria | British Columbia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | St. John's Mercy Medical Center | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), Hamilton Academy of Health Science Research Organization (HAHSO), Physician's Services Incorporated (PSI), Technology Evaluation in the Elderly Network (TVN) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pilot Trial - Feasibility | Is it feasible to perform a large RCT in mechanically ventilated critically ill patients to investigate whether orally ingested L. rhamnosus GG prevents VAP, based on successful and timely pilot trial recruitment; high adherence to protocol; minimal contamination; and an acceptable VAP rate? | 90 days |
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