Clinical trial NCT01258842: Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Prevention
Probiotic
Lead sponsor: Fonterra Research Centre
Sponsor class: INDUSTRY
Collaborators: name: Danisco
name: Sprim Advanced Life Sciences
First posted: 2010-12-13
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 outcomes:
measure: Influenza infection
timeFrame: 12 weeks
Secondary outcomes:
measure: Symptom duration
timeFrame: 12 weeks
measure: Symptom severity
timeFrame: 12 weeks
measure: Adverse event incidence
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Rochester
country: United States
facility: Remedica, LLC
state: Michigan
Study officials:
affiliation: Milano University Medical School
name: Mario Clerici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Milan
name: Emilio Clementi
role: PRINCIPAL_INVESTIGATOR
References: