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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Probiotic placebo | Placebo Comparator | Participants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Dietary Supplement | Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| antimicrobial prescriptions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD | McMaster University, Hamilton, ON, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Clarion | Hamilton | Ontario | L8G 1E7 | Canada | ||
| Pine Villa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29741754 | Derived | 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. |
| Label | URL |
|---|---|
| McMaster University, Faculty of Health Sciences, Dr. Mark Loeb | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| probiotic placebo | Other | Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months. |
|
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 |
| 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 |
| 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 |
| Hamilton |
| Ontario |
| L8G 1G6 |
| Canada |
| Arbour Creek | Hamilton | Ontario | L8G 1J3 | Canada |
| Parkview Nursing centre | Hamilton | Ontario | L8P 1C1 | Canada |
| Dundurn Place | Hamilton | Ontario | L8R 3L8 | Canada |
| Shalom Village | Hamilton | Ontario | L8S 3S1 | Canada |
| The Wellington | Hamilton | Ontario | L9A 5H5 | Canada |
| Idlewyld Manor | Hamilton | Ontario | L9C2A9 | Canada |
| Regina Gardens | Hamilton | Ontario | L9C5E3 | Canada |
| St. Peter's Chedoke | Hamilton | Ontario | L9C7W9 | Canada |
| Wentworth Lodge | Hamilton | Ontario | L9H 4C4 | Canada |
| Blackadar Continuing Care | Hamilton | Ontario | L9H 5G7 | Canada |
| St. Joseph's Villa | Hamilton | Ontario | L9H 5G7 | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D019602 |
| Food and Beverages |