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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by McMaster University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01782755
First received: January 29, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Ventilator Associated Pneumonia (VAP)
Infection
Antibiotic-Associated Diarrhea
C-Difficile
Drug: L. rhamnosus GG - Probiotic
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT): A Feasibility Clinical Trial

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Pilot Trial - Feasibility [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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?


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactobacillus rhamnosus GG
Patients allocated to the intervention group will receive 1x1010 colony forming units (CFU) of Lactobacillus rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule suspended in sterile water, administered through a nasogastric, nasoduodenal, percutaneous gastrostomy or percutaneous jejunal tube twice daily while patients are mechanically ventilated until 24 hours of spontaneous breathing. The first dose will be within 48 hours of intubation.
Drug: L. rhamnosus GG - Probiotic
Twice daily, patients will receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule
Other Name: Culturelle Probiotic
Placebo Comparator: Placebo
Patients allocated to the placebo group will receive a capsule identical in appearance to the L. rhamnosus GG capsule, but containing microcrystalline cellulose. The placebo will also be suspended in sterile water and similarly administered twice a day. When suspended in water, the placebo has identical appearance and consistency as the probiotic. The placebo will be prepared by the manufacturer of L. rhamnosus GG, Culturelle, and has been used successfully in a recent RCT in the ICU population

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults ≥ 18 years of age;
  2. Admitted to any ICU < 48 hours and receiving mechanical ventilation for <48 hours;
  3. Anticipated ventilation of ≥72 hours at the time of enrolment, as per the ICU physician.
  4. Nasogastric or nasoduodenal feeding tube in situ

Exclusion Criteria:

  1. Patients at potential increased risk of iatrogenic probiotic infection including specific immunocompromised populations (HIV <200 CD4 cells/μL, those receiving chronic immunosuppressive medications, prior organ transplant or hematological transplant, current or recent malignancy requiring active follow-up), patients at risk for endovascular infection (history of rheumatic heart disease, congenital heart defect, mechanical valves, history of endocarditis, endovascular grafts, permanent endovascular devices such as permanent [not short-term] hemodialysis catheters or pacemakers), patients with anatomic/mucosal GI tract defects (gastroesophageal or intestinal injury, foregut surgery and/or oropharyngeal mucosal injury, ischemic gut) and severe acute pancreatitis (Ranson score ≥4, [Ranson 1974]);
  2. Strict contraindication or inability to receive enteral medications;
  3. Patients with percutaneous gastric or percutaneous jejuna feeding tubes already in situ
  4. Known or suspected pregnancy - although L. rhamnosus GG has been studied in pregnancy, their safety in critically ill pregnant women is unknown;
  5. Intent to withhold or withdraw advanced life support as per the ICU physician;
  6. Prior history of mechanical ventilation during current hospital stay;
  7. Previous enrolment in this or a potentially confounding trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782755

Contacts
Contact: Deborah J Cook, MD 905-522-1155 ext 35325 debcook@mcmaster.ca
Contact: Nicole L Zytaruk, Reg. N 905-522-1155 ext 35325 zytaruk@mcmaster.ca

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z1Y6
Contact: Peter Dodek, MD    604-806-9023    pedodek@interchange.ubc.ca   
Contact: Betty-Jean Ashley       bjashley@mail.cheos.ubc.ca   
Principal Investigator: Peter Dodek, MD         
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: William Henderson, MD    604-875-5949    william.henderson@vch.ca   
Contact: Denise Foster, RN    604-875-4111 ext 68336    Denise.Foster@vch.ca   
Principal Investigator: William Henderson, MD         
Canada, Ontario
Hamilton Health Science - Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Maureen Meade, MD    905-527-7077    meadema@HHSC.ca   
Contact: Lori Hand, RRT    905-972-1294    handlori@hhsc.ca   
Principal Investigator: Maureen Meade, MD         
Hamilton Health Science - Jurvinski Hospital Not yet recruiting
Hamilton, Ontario, Canada, L8V 1C3
Contact: Maureen Meade, MD    905-527-7077    meadema@hhsc.ca   
Contact: France Clarke, RRT    905-522-1155 ext 33633    clarkef@mcmaster.ca   
Principal Investigator: Maureen Meade, MD         
St Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Deborah Cook, MD    905-522-1155 ext 35325    debcook@mcmaster.ca   
Contact: Nicole Zytaruk, Reg. N    905-522-1155 ext 35325    zytaruk@mcmaster.ca   
Principal Investigator: Deborah Cook, MD         
Ottawa Research Institute - General Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Laurlyn McIntyre, MD    613-737-8899 ext 73231    lmcintyre@ottawahospital.on.ca   
Contact: Irene Watpool, RN    613-737-8724    iwatpool@ottawahospital.on.ca   
Principal Investigator: Lauralyn McIntyre, MD         
Ottawa Hospital Research Institute - Civic Campus Recruiting
Ottawa, Ontario, Canada, K1H 8G7
Contact: Lauralyn McIntyre, MD    613-737-8899 ext 73231    lmcintyre@ottawahospital.on.ca   
Contact: Tracy McArdle, RN    613-798-5555 ext 17076    tmcardle@ottawahospital.on.ca   
Principal Investigator: Lauralyn McIntyre, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Sangeeta Mehta, MD    416-586-4679    samehta@mtsinai.on.ca   
Contact: Brittany Giacomino, RN    416-586-4800 ext 2549    BGiacomino@mtsinai.on.ca   
Principal Investigator: Sangeeta Mehta, MD         
St Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: John Marshall, MD    416-864-6060 ext 3538    marshallj@smh.toronto.on.ca   
Contact: Orla Smith, Reg. N    416-864-6060 ext 3179    smitho@smh.toronto.on.ca   
Principal Investigator: John Marshall, MD         
University Health Network - Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada
Contact: Margaret Herridge, MD    416-340-4800 ext 3057    dr.margaret.herridge@uhn.ca   
Contact: Andrea Matte, RRT    416-340-4800    Andrea.Matte@uhn.on.ca   
Principal Investigator: Margaret Herridge, MD         
Canada, Quebec
Hopital de l'Enfant Jesus Recruiting
Quebec City, Quebec, Canada, G1J 1Z4
Contact: Francois Lauzier, MD    418-649-0252    francois.lauzier@med.ulaval.ca   
Contact: Sara-Judith Breton, RN    418-649-0252    sarah-judith.breton.cha@ssss.gouv.qc.ca   
Principal Investigator: Francois Lauzier, MD         
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Deborah J Cook, MD McMaster University
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01782755     History of Changes
Other Study ID Numbers: 28012013
Study First Received: January 29, 2013
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Probiotics
Ventilator Associated Pneumonia (VAP)
Infection
Antibiotic-Associated Diarrhea
C-Difficile

Additional relevant MeSH terms:
Diarrhea
Infection
Pneumonia
Pneumonia, Ventilator-Associated
Cross Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms
Signs and Symptoms, Digestive
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on October 20, 2014