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

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized, Placebo-controlled Trial of the Effects of Prophylactic Bifidobacterium Lactis HN019 Supplementation on the Incidence of Influenza Infection in Healthy Adults

Conditions
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Influenza

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium lactis HN019
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B. lactis HN019<br> | Dietary Supplement: Bifidobacterium lactis HN019<br>* B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo sachet, consumed once per day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza infection | Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom duration |  | 12 weeks | 
| Symptom severity |  | 12 weeks | 
| Adverse event incidence | The proportion of subjects that reports at least one adverse event (regardless of cause) during the study | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Prevention, Probiotic