Use of Probiotics to Prevent Influenza

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by McMaster University
Sponsor:
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01720329
First received: October 15, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection.


Condition Intervention
Influenza
Dietary Supplement: Probiotics
Other: probiotic placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Probiotics to Prevent Influenza and Other Respiratory Infections in Residents of Long-term Care Facilities: A Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study [ Time Frame: Participants will be assessed twice weekly for symptoms for 12 months. This will begin after they have been randomized to probiotics or placebo arms of the study ] [ Designated as safety issue: No ]
    this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR)


Secondary Outcome Measures:
  • influenza like illness [ Time Frame: Participants will be assessed twice weekly for 12 months after they have been randomized into probiotics or placebo ] [ Designated as safety issue: No ]
    influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity

  • antimicrobial prescriptions [ Time Frame: To be reviewed at the twice weekly assessments for 12 months following randomization ] [ Designated as safety issue: No ]
    courses of antimicrobials (name, does and duration) will be recorded by research nurse using information on the medication container or by contacting the prescribing physician if necessary

  • physician visits for respiratory illness [ Time Frame: The participant's MD patient record will be reviewed for visits during the 12 months following randomization ] [ Designated as safety issue: No ]
    information will be obtained from the attending physician

  • hospitalizations for lower respiratory infection or pneumonia [ Time Frame: Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 12 months following randomization ] [ Designated as safety issue: No ]
    cause of hospitalizations will be assessed by the research nurse through interviews with the participants and reviews of hospital medical records. Deaths will be recorded using medical records


Estimated Enrollment: 1440
Study Start Date: July 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotics
Participants randomized to probiotics will receive XXmls of XXX supplemented with L. rhamnosus GG on a daily basis for six months
Dietary Supplement: Probiotics
Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
Placebo Comparator: probiotic placebo
participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months
Other: probiotic placebo
Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.

Detailed Description:

The goal of this study is to assess the feasibility of randomizing residents of long-term care facilities to either probiotics or placebo to assess whether probiotics can reduce influenza and other viral laboratory confirmed respiratory infection. The investigators will determine whether it is feasible to enroll residents and randomize them to a daily course of probiotics or placebo and monitor for influenza and other respiratory tract infections. In addition, the investigators will asses the feasibility of obtaining a nasal specimen for evaluation of the upper respiratory microbiome, measure antimicrobials, and deterioration in functional status. All aspects of the proposed trial will be assessed, including enrollment, randomization, respiratory infection surveillance, methods for outcome assessment, and event rates. The investigators will test the use of our data collection forms and data management strategy and will generate date to derive an appropriate sample size.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • nursing home residents, 65 years of age or older, in the Hamilton ON area

Exclusion Criteria:

  • residents who are immunosuppressed (steroids or other immunosuppressives), have a hematologic malignancy, structural heart disease, gastroesophageal or intestinal injury and those are at increased risk of an endovascular infection will be excluded
  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: NCT01720329

Contacts
Contact: Sasha Eskandarian 905-525-9140 ext x26672 eskand@mcmaster.ca

Locations
Canada, Ontario
Wentworth Lodge Recruiting
Hamilton, Ontario, Canada, L9H 4C4
Contact: Tom Hunter    905-546-2854 ext 1900    Tom.Hunter@hamilton.ca   
Contact: Amy Bartholomew, RN    905-525-9140 ext 26670    barthol@mcmaster.ca   
St. Joseph's Villa Recruiting
Hamilton, Ontario, Canada, L9H 5G7
Contact: Mieke Ewen    905-627-3541 ext 2236    m_ewen@sjv.on.ca   
Shalom Village Recruiting
Hamilton, Ontario, Canada, L8S 3S1
Contact: Adrienne Cunnane    905-529-1613    Adrienne@shalomvillage.ca   
Contact: Priscilla Bowler    905-529-1613    Priscilla@shalomvillage.ca   
The Clarion Recruiting
Hamilton, Ontario, Canada, L8G 1E7
Contact: Barbara Szeremeta    905-664-2281 ext 22    doc@clarionnursinghoe.on.ca   
Arbour Creek Recruiting
Hamilton, Ontario, Canada, L8G 1J3
Contact: Lily Wang    905-572-4925    lilywang@thomashealthcare.com   
Pine Villa Recruiting
Hamilton, Ontario, Canada, L8G 1G6
Contact: Paula White    905-573-4900 ext 3231    pwhite@thomashealthcare.com   
Sponsors and Collaborators
McMaster University
Investigators
Principal Investigator: Mark Loeb, MD McMaster University, Hamilton, ON, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01720329     History of Changes
Other Study ID Numbers: PPI-2012
Study First Received: October 15, 2012
Last Updated: November 7, 2013
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on July 22, 2014