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 |
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.
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
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