Status:
UNKNOWN
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
Lead Sponsor:
Fonterra Research Centre
Collaborating Sponsors:
Danisco
Sprim Advanced Life Sciences
Conditions:
Influenza
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
426 Patients enrolled
Trial Details
Trial ID
NCT01258842
Start Date
December 1 2010
End Date
May 1 2011
Last Update
December 13 2010
Active Locations (2)
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1
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
2
Remedica, LLC
Rochester, Michigan, United States, 48307