Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 60
Updated:4/2/2016
Start Date:December 2010
End Date:May 2011
Contact:Tisha Golden
Email:tisha.golden@sprim.com

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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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

- 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
We found this trial at
2
sites
Rochester, Michigan 48307
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from
Rochester, MI
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801 Monterey Street
Coral Gables, Florida 33134
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from
Coral Gables, FL
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