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

Phase 3

• Conditions: Influenza
• Interventions: Dietary Supplement: Bifidobacterium lactis HN019; Dietary Supplement: Placebo

• Registration Number: NCT01258842
• Lead Sponsor: Fonterra Research Centre

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study Start: 2010-12
• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-10
• Last Update Submitted: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Posted: 2010-12-13
• Primary Completion: 2011-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 426

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B. lactis HN019	Bifidobacterium lactis HN019	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Influenza infection	12 weeks	Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period

Secondary Outcome Measures

Name	Time	Method
Symptom duration	12 weeks
Symptom severity	12 weeks
Adverse event incidence	12 weeks	The proportion of subjects that reports at least one adverse event (regardless of cause) during the study

Trial Locations

Locations (2)

Remedica, LLC; 🇺🇸 Rochester, Michigan, United States

Clinical Research of South Florida; 🇺🇸 Coral Gables, Florida, United States