Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
NCT ID: NCT01258842
Last Updated: 2010-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
426 participants
INTERVENTIONAL
2010-12-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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B. lactis HN019
Bifidobacterium lactis HN019
B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
Placebo
Placebo
Placebo sachet, consumed once per day for 12 weeks
Interventions
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Bifidobacterium lactis HN019
B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
Placebo
Placebo sachet, consumed once per day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Danisco
INDUSTRY
Sprim Advanced Life Sciences
OTHER
Fonterra Research Centre
INDUSTRY
Responsible Party
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Fonterra Research Centre
Principal Investigators
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Mario Clerici, MD
Role: PRINCIPAL_INVESTIGATOR
Milano University Medical School
Emilio Clementi
Role: PRINCIPAL_INVESTIGATOR
University of Milan
Locations
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Clinical Research of South Florida
Coral Gables, Florida, United States
Remedica, LLC
Rochester, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Jeffrey Rosen, MD
Role: primary
Rica Stamatin, MD
Role: primary
Other Identifiers
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10-SBUS-6-FON-02
Identifier Type: -
Identifier Source: org_study_id