Use of Probiotics to Prevent Influenza

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of Probiotics to Prevent Influenza and Other Respiratory Infections in Residents of Long-term Care Facilities: A Pilot Study

Conditions
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Influenza

Intervention / Treatment
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* Dietary Supplement: Probiotics
* Other: probiotic placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotics<br>Participants randomized to probiotics will receive 2 capsules supplemented with 10 billion cfu of Lactobacillus rhamnosus GG on a daily basis for six months | Dietary Supplement: Probiotics<br>* Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months<br>|
| Placebo Comparator: Probiotic placebo<br>Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months | Other: probiotic placebo<br>* Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study | this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza like illness | influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity | Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo | 
| antimicrobial prescriptions | 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. | To be reviewed at the twice weekly assessments for 6 months following randomization | 
| physician visits for respiratory illness | information will be obtained from the attending physician | The participant's MD patient record will be reviewed for visits during the 12 months following randomization | 
| hospitalizations for lower respiratory infection or pneumonia | 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 | Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization |