Influenza
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
OTHERprobiotic placebo
Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study | 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 | this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| influenza like illness | Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo | influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity |
| antimicrobial prescriptions | To be reviewed at the twice weekly assessments for 6 months following randomization | 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. |
| physician visits for respiratory illness | The participant's MD patient record will be reviewed for visits during the 12 months following randomization | information will be obtained from the attending physician |
| hospitalizations for lower respiratory infection or pneumonia | Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization | 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 |
Countries
Canada
Outcome results
None listed