Use of Probiotics to Prevent Influenza

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Dietary supplement: Probiotics; Other: probiotic placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8G 1E7
      • The Clarion
    • Hamilton, Ontario, Canada, L8G 1G6
      • Pine Villa
    • Hamilton, Ontario, Canada, L8G 1J3
      • Arbour Creek
    • Hamilton, Ontario, Canada, L8P 1C1
      • Parkview Nursing centre
    • Hamilton, Ontario, Canada, L8R 3L8
      • Dundurn Place
    • Hamilton, Ontario, Canada, L8S 3S1
      • Shalom Village
    • Hamilton, Ontario, Canada, L9A 5H5
      • The Wellington
    • Hamilton, Ontario, Canada, L9C2A9
      • Idlewyld Manor
    • Hamilton, Ontario, Canada, L9C5E3
      • Regina Gardens
    • Hamilton, Ontario, Canada, L9C7W9
      • St. Peter's Chedoke
    • Hamilton, Ontario, Canada, L9H 4C4
      • Wentworth Lodge
    • Hamilton, Ontario, Canada, L9H 5G7
      • Blackadar Continuing Care
    • Hamilton, Ontario, Canada, L9H 5G7
      • St. Joseph's Villa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; 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; Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
Placebo Comparator: Probiotic placebo; Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months	Other: probiotic placebo; Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Mark Loeb, MD, McMaster University, Hamilton, ON, Canada

Publications and helpful links

General Publications

• 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.

Helpful Links

• McMaster University, Faculty of Health Sciences, Dr. Mark Loeb

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 2, 2012

Study Record Updates

• Last Update Posted (Actual): October 26, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: PPI-2012