Use of Probiotics to Prevent Influenza

N/ACompletedNCT01720329

McMaster University1,440 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,440

Conditions

Influenza

Interventions

ProbioticsDIETARY_SUPPLEMENT

Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months

probiotic placeboOTHER

Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (13)

The Clarion

Hamilton, Ontario, Canada

Pine Villa

Hamilton, Ontario, Canada

Arbour Creek

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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)

Time frame: 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

influenza like illness

influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization

Data from ClinicalTrials.gov

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