Use of Probiotics to Prevent Influenza

NCT ID: NCT01720329

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-10-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

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

Probiotic placebo

Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months

Group Type: PLACEBO_COMPARATOR

probiotic placebo

Intervention Type: OTHER

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

Interventions

Probiotics

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

Intervention Type: DIETARY_SUPPLEMENT

probiotic placebo

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Loeb, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Hamilton, ON, Canada

Locations

The Clarion

Hamilton, Ontario, Canada

Pine Villa

Hamilton, Ontario, Canada

Arbour Creek

Hamilton, Ontario, Canada

Parkview Nursing centre

Hamilton, Ontario, Canada

Dundurn Place

Hamilton, Ontario, Canada

Shalom Village

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

Wentworth Lodge

Hamilton, Ontario, Canada

Blackadar Continuing Care

Hamilton, Ontario, Canada

St. Joseph's Villa

Hamilton, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29741754 (View on PubMed)

Related Links

http://mcmaster.ca

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

Other Identifiers

PPI-2012

Identifier Type: -

Identifier Source: org_study_id