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Completed

NCT Number: NCT01720329

Use of Probiotics to Prevent Influenza

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arbour Creek, Hamilton, Ontario, Canada

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About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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

probiotic placebo

Other

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

Primary outcomes

  1. laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study

    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

    this will be confirmed on the basis of reverse transcriptase Polymerase Chain Reaction(PCR)

Secondary outcomes

  1. influenza like illness

    Time frame: 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

  2. antimicrobial prescriptions

    Time frame: 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.

  3. physician visits for respiratory illness

    Time frame: 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

  4. hospitalizations for lower respiratory infection or pneumonia

    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

    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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2012
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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