Use of Probiotics to Prevent Influenza

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01720329
• Other study ID #: PPI-2012
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: October 2017

Study information

• Verified date: October 2018
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1440
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Dietary Supplement:
• Probiotics
Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG 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.

Locations

Country	Name	City	State
Canada	Arbour Creek	Hamilton	Ontario
Canada	Blackadar Continuing Care	Hamilton	Ontario
Canada	Dundurn Place	Hamilton	Ontario
Canada	Idlewyld Manor	Hamilton	Ontario
Canada	Parkview Nursing centre	Hamilton	Ontario
Canada	Pine Villa	Hamilton	Ontario
Canada	Regina Gardens	Hamilton	Ontario
Canada	Shalom Village	Hamilton	Ontario
Canada	St. Joseph's Villa	Hamilton	Ontario
Canada	St. Peter's Chedoke	Hamilton	Ontario
Canada	The Clarion	Hamilton	Ontario
Canada	The Wellington	Hamilton	Ontario
Canada	Wentworth Lodge	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

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