Use of Probiotics to Prevent Influenza

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Other: probiotic placebo; Dietary Supplement: Probiotics

• Registration Number: NCT01720329
• Lead Sponsor: McMaster University

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.

Study Timeline

• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Study Start: 2013-07
• Primary Completion: 2017-08
• Study Completion: 2017-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1440

Inclusion Criteria

• nursing home residents, 65 years of age or older, in the Hamilton ON area

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic placebo	probiotic placebo	Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months
Probiotics	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

Primary Outcome Measures

Name	Time	Method
laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study	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 Outcome Measures

Name	Time	Method
influenza like illness	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
antimicrobial prescriptions	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.
physician visits for respiratory illness	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
hospitalizations for lower respiratory infection or pneumonia	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

Trial Locations

Locations (13)

Dundurn Place; 🇨🇦 Hamilton, Ontario, Canada

Pine Villa; 🇨🇦 Hamilton, Ontario, Canada

Arbour Creek; 🇨🇦 Hamilton, Ontario, Canada

Shalom Village; 🇨🇦 Hamilton, Ontario, Canada

Parkview Nursing centre; 🇨🇦 Hamilton, Ontario, Canada

The Wellington; 🇨🇦 Hamilton, Ontario, Canada

Idlewyld Manor; 🇨🇦 Hamilton, Ontario, Canada

Regina Gardens; 🇨🇦 Hamilton, Ontario, Canada

St. Peter's Chedoke; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Villa; 🇨🇦 Hamilton, Ontario, Canada

Wentworth Lodge; 🇨🇦 Hamilton, Ontario, Canada

Blackadar Continuing Care; 🇨🇦 Hamilton, Ontario, Canada

The Clarion; 🇨🇦 Hamilton, Ontario, Canada