<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01720329</url>
  </required_header>
  <id_info>
    <org_study_id>PPI-2012</org_study_id>
    <nct_id>NCT01720329</nct_id>
  </id_info>
  <brief_title>Use of Probiotics to Prevent Influenza</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess the feasibility of randomizing residents of long-term&#xD;
      care facilities to either probiotics or placebo to assess whether probiotics can reduce&#xD;
      influenza and other viral laboratory confirmed respiratory infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to assess the feasibility of randomizing residents of long-term&#xD;
      care facilities to either probiotics or placebo to assess whether probiotics can reduce&#xD;
      influenza and other viral laboratory confirmed respiratory infection. The investigators will&#xD;
      determine whether it is feasible to enroll residents and randomize them to a daily course of&#xD;
      probiotics or placebo and monitor for influenza and other respiratory tract infections. In&#xD;
      addition, the investigators will asses the feasibility of obtaining a nasal specimen for&#xD;
      evaluation of the upper respiratory microbiome, measure antimicrobials, and deterioration in&#xD;
      functional status. All aspects of the proposed trial will be assessed, including enrollment,&#xD;
      randomization, respiratory infection surveillance, methods for outcome assessment, and event&#xD;
      rates. The investigators will test the use of our data collection forms and data management&#xD;
      strategy and will generate date to derive an appropriate sample size.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study</measure>
    <time_frame>Participants will be assessed twice weekly for symptoms for 6 months. This will begin after they have been randomized to probiotics or placebo arms of the study</time_frame>
    <description>this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>influenza like illness</measure>
    <time_frame>Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo</time_frame>
    <description>influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>antimicrobial prescriptions</measure>
    <time_frame>To be reviewed at the twice weekly assessments for 6 months following randomization</time_frame>
    <description>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. We will measure antibiotic associated diarrhea which we define as ≥ 3 liquid stools/d for at least two day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physician visits for respiratory illness</measure>
    <time_frame>The participant's MD patient record will be reviewed for visits during the 12 months following randomization</time_frame>
    <description>information will be obtained from the attending physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospitalizations for lower respiratory infection or pneumonia</measure>
    <time_frame>Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1440</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Probiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to probiotics will receive 2 capsules supplemented with 10 billion cfu of Lactobacillus rhamnosus GG on a daily basis for six months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotics</intervention_name>
    <description>Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months</description>
    <arm_group_label>Probiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>probiotic placebo</intervention_name>
    <description>Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.</description>
    <arm_group_label>Probiotic placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nursing home residents, 65 years of age or older, in the Hamilton ON area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  residents who are immunosuppressed (steroids or other immunosuppressives), have a&#xD;
             hematologic malignancy, structural heart disease, gastroesophageal or intestinal&#xD;
             injury and those are at increased risk of an endovascular infection will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Loeb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University, Hamilton, ON, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Clarion</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8G 1E7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pine Villa</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8G 1G6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arbour Creek</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8G 1J3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Nursing centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8P 1C1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dundurn Place</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8R 3L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shalom Village</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 3S1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Wellington</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9A 5H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idlewyld Manor</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9C2A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regina Gardens</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9C5E3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Peter's Chedoke</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9C7W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wentworth Lodge</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9H 4C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blackadar Continuing Care</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9H 5G7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Villa</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L9H 5G7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://mcmaster.ca</url>
    <description>McMaster University, Faculty of Health Sciences, Dr. Mark Loeb</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720329
org study id: PPI-2012
nct id: NCT01720329
lead sponsor: 
has dmc: No
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 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: 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 6 months. This will begin after they have been randomized to probiotics or placebo arms of the study
description: this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR)
measure: influenza like illness
time frame: Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo
description: influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity
measure: antimicrobial prescriptions
time frame: To be reviewed at the twice weekly assessments for 6 months following randomization
description: 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. We will measure antibiotic associated diarrhea which we define as ≥ 3 liquid stools/d for at least two day.
measure: physician visits for respiratory illness
time frame: The participant's MD patient record will be reviewed for visits during the 12 months following randomization
description: information will be obtained from the attending physician
measure: 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 6 months following randomization
description: 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
arm group label: Probiotics
arm group type: Active Comparator
description: Participants randomized to probiotics will receive 2 capsules supplemented with 10 billion cfu of Lactobacillus rhamnosus GG on a daily basis for six months
arm group label: Probiotic placebo
arm group type: Placebo Comparator
description: Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months
intervention type: Dietary Supplement
intervention name: Probiotics
description: Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
arm group label: Probiotics
intervention type: Other
intervention name: probiotic placebo
description: Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.
arm group label: Probiotic placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Loeb, MD
role: Principal Investigator
affiliation: McMaster University, Hamilton, ON, Canada
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
url: http://mcmaster.ca
description: McMaster University, Faculty of Health Sciences, Dr. Mark Loeb
responsible party type: Sponsor
mesh term: Influenza, Human