InfluenzaPhase 3NCT01258842
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
A Phase 3 study testing Bifidobacterium lactis HN019 in people with Influenza, run by Fonterra Research Centre at 2 sites in United States.
Trial summary
To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Bifidobacterium lactis HN019
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy free-living men and women aged 18 to 60 years
- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
- Subject owns a refrigerator and is willing to keep study product refrigerated at all times
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects
- Consent to the study and willing to comply with study product and methods
Who cannot join
- Influenza vaccination in last 6 months, or any other vaccination in previous 15 days
- Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- Chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, COPD, as determined by medical history and baseline physical examination)
- Chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin C)
- Use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics)
- Contraindication to dairy products or any other substance in the study product (eg, lactose intolerance)
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- History of alcohol, drug, or medication abuse
- Pregnant or lactating female, or pregnancy planned during study period
- Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 3 months of screening
- Participation in another study with any investigational product within 3 months of screening
- Investigator believes that the participant may be uncooperative and/or noncompliant, and should therefore not participate in the study
Trial locations and contacts
2 sites in 1 country.
Tisha Golden contact
United States2 sites, 2 recruiting
- Recruiting
Clinical Research of South Florida
Coral Gables, Florida, 33134
Jeffrey Rosen, MD, 305-445-5637
Jeffrey Rosen, MD
- Recruiting
Remedica, LLC
Rochester, Michigan, 48307
Rica Stamatin, MD, 248-650-7870
Rica Stamatin, MD
About this study
Official title: Double-blind, Randomized, Placebo-controlled Trial of the Effects of Prophylactic Bifidobacterium Lactis HN019 Supplementation on the Incidence of Influenza Infection in Healthy Adults
To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.
- Conditions
- Influenza
- Being tested
- Bifidobacterium lactis HN019, Placebo
- Keywords
- Influenza, Prevention, Probiotic
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactis HN019Dietary supplement
- lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
PlaceboDietary supplement
Placebo sachet, consumed once per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| B. lactis HN019 | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium lactis HN019 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza infection
Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
Measured: 12 weeks
Secondary outcomes (3)
Symptom duration
Measured: 12 weeks
Symptom severity
Measured: 12 weeks
Adverse event incidence
The proportion of subjects that reports at least one adverse event (regardless of cause) during the study
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danisco, Sprim Advanced Life Sciences
- Investigators
- Mario Clerici, MD, Principal investigator, Milano University Medical SchoolEmilio Clementi, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258842
- Sponsor's protocol ID
- 10-SBUS-6-FON-02
- Status last verified
- Dec 2010
- First submitted
- 9 Dec 2010
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled Trial of the Effects of Prophylactic Bifidobacterium Lactis HN019 Supplementation on the Incidence of Influenza Infection in Healthy Adults
- ClinicalTrials.gov ID
- NCT01258842
- Acronym / sponsor ID
- 10-SBUS-6-FON-02
- Conditions
- Influenza
- Keywords
- Influenza, Prevention, Probiotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- Danisco, Sprim Advanced Life Sciences
- Study start
- Dec 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 13 Dec 2010 (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.
To determine if prophylactic supplementation with B. lactis HN019 reduces the risk of developing physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B. lactis HN019 | Experimental | Dietary Supplement: Bifidobacterium lactis HN019 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy free-living men and women aged 18 to 60 years
- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
- Subject owns a refrigerator and is willing to keep study product refrigerated at all times
- Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study, including possible risks and side effects
- Consent to the study and willing to comply with study product and methods
Key exclusion criteria (11 listed)
- Influenza vaccination in last 6 months, or any other vaccination in previous 15 days
- Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial
- Chronic nasal, laryngeal, pleural, or respiratory condition that could mimic or obscure symptoms of influenza (e.g. chronic allergic rhinitis, asthma, COPD, as determined by medical history and baseline physical examination)
- Chronic use of medication(s) that could suppress or prevent flu-like symptoms (eg, antihistamines, cough medicines; echinacea, high-dose vitamin C)
- Use of medication(s) within the previous 3 months that affect immune response (eg, antibiotics)
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 |
|---|---|---|
| Bifidobacterium lactis HN019B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks | Dietary supplement | B. lactis HN019 |
| PlaceboPlacebo sachet, consumed once per day for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Influenza infection
Time frame: 12 weeks
Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
3 secondary outcomes
Symptom duration
Time frame: 12 weeks
Symptom severity
Time frame: 12 weeks
Adverse event incidence
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
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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.
Tisha Golden contact
Mario Clerici, MD principal investigator
Milano University Medical School
Emilio Clementi principal investigator
University of Milan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bifidobacterium lactis HN019 in people with Influenza, run by Fonterra Research Centre at 2 sites in United States.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tisha Golden (tisha.golden@sprim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza infection (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2010.