NCT01720329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

4.1 years

First QC Date

October 15, 2012

Last Update Submit

October 25, 2018

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • influenza like illness

    Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo

  • antimicrobial prescriptions

    To be reviewed at the twice weekly assessments for 6 months following randomization

  • physician visits for respiratory illness

    The participant's MD patient record will be reviewed for visits during the 12 months following randomization

  • 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

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

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

Probiotic placebo

PLACEBO COMPARATOR

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

Other: probiotic placebo

Interventions

ProbioticsDIETARY_SUPPLEMENT

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

Probiotics
probiotic placeboOTHER

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

Probiotic placebo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

The Clarion

Hamilton, Ontario, L8G 1E7, Canada

Location

Pine Villa

Hamilton, Ontario, L8G 1G6, Canada

Location

Arbour Creek

Hamilton, Ontario, L8G 1J3, Canada

Location

Parkview Nursing centre

Hamilton, Ontario, L8P 1C1, Canada

Location

Dundurn Place

Hamilton, Ontario, L8R 3L8, Canada

Location

Shalom Village

Hamilton, Ontario, L8S 3S1, Canada

Location

The Wellington

Hamilton, Ontario, L9A 5H5, Canada

Location

Idlewyld Manor

Hamilton, Ontario, L9C2A9, Canada

Location

Regina Gardens

Hamilton, Ontario, L9C5E3, Canada

Location

St. Peter's Chedoke

Hamilton, Ontario, L9C7W9, Canada

Location

Wentworth Lodge

Hamilton, Ontario, L9H 4C4, Canada

Location

Blackadar Continuing Care

Hamilton, Ontario, L9H 5G7, Canada

Location

St. Joseph's Villa

Hamilton, Ontario, L9H 5G7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29741754DERIVED

Related Links

MeSH Terms

Conditions

Influenza, Human

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Mark Loeb, MD

    McMaster University, Hamilton, ON, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2012

First Posted

November 2, 2012

Study Start

July 1, 2013

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

CA(13)