Use of Probiotics to Prevent Influenza
This study is not yet open for participant recruitment.
Verified October 2012 by McMaster University
Sponsor:
McMaster University
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT01720329
First received: October 15, 2012
Last updated: October 31, 2012
Last verified: October 2012
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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 |
| 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 and be followed 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)
- laboratory-confirmed influenza or other respiratory viral infection in participants from placebo arm of the study [ Time Frame: Participants will be assessed twice weekly for 12 months following randomization into 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 and follwed 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: | January 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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
|
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 immuno-suppressed (steroids or other immuno-suppressives), 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
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 | |
| Nursing Homes | Not yet recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Sasha Eskandarian 905-525-9140 ext 26672 eskand@mcmaster.ca | |
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: | October 31, 2012 |
| 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 May 23, 2013