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

Fonterra

Status and phase

Unknown

Phase 3

Conditions

Influenza

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Bifidobacterium lactis HN019

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01258842

10-SBUS-6-FON-02

Details and patient eligibility

About

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.

Enrollment

426 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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