Use of Probiotics to Prevent Influenza

McMaster University

Status: Completed

Conditions: Influenza

Treatments: Other: probiotic placebo; Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT01720329

PPI-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,440 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

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

Treatment:

Dietary Supplement: Probiotics

Probiotic placebo

Placebo Comparator group

Description:

Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months

Treatment:

Other: probiotic placebo