Clinical trial NCT01720329: Use of Probiotics to Prevent Influenza
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 1440
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study
timeFrame: 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 outcomes:
measure: influenza like illness
timeFrame: Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo
measure: antimicrobial prescriptions
timeFrame: To be reviewed at the twice weekly assessments for 6 months following randomization
measure: physician visits for respiratory illness
timeFrame: The participant's MD patient record will be reviewed for visits during the 12 months following randomization
measure: hospitalizations for lower respiratory infection or pneumonia
timeFrame: Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: The Clarion
state: Ontario
city: Hamilton
country: Canada
facility: Pine Villa
state: Ontario
city: Hamilton
country: Canada
facility: Arbour Creek
state: Ontario
city: Hamilton
country: Canada
facility: Parkview Nursing centre
state: Ontario
city: Hamilton
country: Canada
facility: Dundurn Place
state: Ontario
city: Hamilton
country: Canada
facility: Shalom Village
state: Ontario
city: Hamilton
country: Canada
facility: The Wellington
state: Ontario
city: Hamilton
country: Canada
facility: Idlewyld Manor
state: Ontario
city: Hamilton
country: Canada
facility: Regina Gardens
state: Ontario
city: Hamilton
country: Canada
facility: St. Peter's Chedoke
state: Ontario
city: Hamilton
country: Canada
facility: Wentworth Lodge
state: Ontario
city: Hamilton
country: Canada
facility: Blackadar Continuing Care
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Villa
state: Ontario
Study officials:
affiliation: McMaster University, Hamilton, ON, Canada
name: Mark Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang B, Hylwka T, Smieja M, Surrette M, Bowdish DME, Loeb M. Probiotics to Prevent Respiratory Infections in Nursing Homes: A Pilot Randomized Controlled Trial. J Am Geriatr Soc. 2018 Jul;66(7):1346-1352. doi: 10.1111/jgs.15396. Epub 2018 May 9.