InfluenzaNCT01720329
Use of Probiotics to Prevent Influenza
A study testing Probiotics in people with Influenza, run by McMaster University at 13 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,440 participants
- Where
- 13 sitesCanada
- Study dates
- Jul 2013to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- nursing home residents, 65 years of age or older, in the Hamilton ON area
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
The Clarion
Hamilton, Ontario, L8G 1E7
Pine Villa
Hamilton, Ontario, L8G 1G6
Arbour Creek
Hamilton, Ontario, L8G 1J3
Parkview Nursing centre
Hamilton, Ontario, L8P 1C1
Dundurn Place
Hamilton, Ontario, L8R 3L8
Shalom Village
Hamilton, Ontario, L8S 3S1
The Wellington
Hamilton, Ontario, L9A 5H5
Idlewyld Manor
Hamilton, Ontario, L9C2A9
Regina Gardens
Hamilton, Ontario, L9C5E3
St. Peter's Chedoke
Hamilton, Ontario, L9C7W9
Wentworth Lodge
Hamilton, Ontario, L9H 4C4
Blackadar Continuing Care
Hamilton, Ontario, L9H 5G7
St. Joseph's Villa
Hamilton, Ontario, L9H 5G7
About this study
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
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.
Read the 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
- Being tested
- Probiotics, probiotic placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
probiotic placeboOther
Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: probiotic placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
influenza-like illness will be defined by the presence of fever, sore throat, and cough and will measure symptom severity
Measured: Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo
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.
Measured: 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
Measured: 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
Measured: Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startJul 2013
- Primary completionAug 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Loeb, MD, Principal investigator, McMaster University, Hamilton, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720329
- Sponsor's protocol ID
- PPI-2012
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2012
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29741754
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01720329
- Acronym / sponsor ID
- PPI-2012
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: ProbioticsParticipants 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 | Other: probiotic placeboParticipants randomized to placebo will receive 2 capsules of matching placebo on a daily basis for six months |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- nursing home residents, 65 years of age or older, in the Hamilton ON area
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsActive comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months | Dietary supplement | Probiotics |
| probiotic placeboPlacebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months. | Other | Probiotic placebo |
Primary outcome
laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study
Time frame: 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)
4 secondary outcomes
influenza like illness
Time frame: Participants will be assessed twice weekly for 6 months after they have been randomized into probiotics or placebo
antimicrobial prescriptions
Time frame: To be reviewed at the twice weekly assessments for 6 months following randomization
physician visits for respiratory illness
Time frame: The participant's MD patient record will be reviewed for visits during the 12 months following randomization
hospitalizations for lower respiratory infection or pneumonia
Time frame: Patient will be asked during the twice weekly assessments about any hospitalizations, as well as consulting their MD, during the 6 months following randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 29741754Wang 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.
- McMaster University, Faculty of Health Sciences, Dr. Mark LoebLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Loeb, MD principal investigator
McMaster University, Hamilton, ON, Canada
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Influenza, run by McMaster University at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laboratory-confirmed influenza or other respiratory viral infection in participants in intervention arm of study (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01720329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.