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

ClinicalTrials.gov ID

NCT01258842

Lead Sponsor

Fonterra Research CentreINDUSTRY

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

426Estimated

Last Update Posted

Dec 13, 2010Estimated

Start Date

Dec 2010

Primary Completion Date

May 2011Estimated

Completion Date

May 2011Estimated

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

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 period.

• Influenza

• Bifidobacterium lactis HN019
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Fonterra Research CentreINDUSTRY

Collaborators

DaniscoINDUSTRY

Sprim Advanced Life SciencesOTHER

248-650-7870

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