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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Influenza	Dietary Supplement: Bifidobacterium lactis HN019; Dietary Supplement: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	426 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
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 Start Date :	December 2010
Estimated Primary Completion Date :	May 2011
Estimated Study Completion Date :	May 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: B. lactis HN019	Dietary Supplement: Bifidobacterium lactis HN019; B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Placebo sachet, consumed once per day for 12 weeks

Outcome Measures

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Primary Outcome Measures :

1. Influenza infection [ Time Frame: 12 weeks ]
   Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period

Secondary Outcome Measures :

1. Symptom duration [ Time Frame: 12 weeks ]
2. Symptom severity [ Time Frame: 12 weeks ]
3. Adverse event incidence [ Time Frame: 12 weeks ]
   The proportion of subjects that reports at least one adverse event (regardless of cause) during the study

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Tisha Golden		tisha.golden@sprim.com

Locations

United States, Florida
Clinical Research of South Florida	Recruiting
Coral Gables, Florida, United States, 33134
Contact: Jeffrey Rosen, MD 305-445-5637
Principal Investigator: Jeffrey Rosen, MD
United States, Michigan
Remedica, LLC	Recruiting
Rochester, Michigan, United States, 48307
Contact: Rica Stamatin, MD 248-650-7870
Principal Investigator: Rica Stamatin, MD

Sponsors and Collaborators

Fonterra Research Centre

Danisco

Sprim Advanced Life Sciences

Investigators

Principal Investigator:	Mario Clerici, MD	Milano University Medical School
Principal Investigator:	Emilio Clementi	University of Milan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pramod Gopral, PhD, Fonterra Research Centre
ClinicalTrials.gov Identifier:	NCT01258842 History of Changes
Other Study ID Numbers:	10-SBUS-6-FON-02
First Posted:	December 13, 2010
Last Update Posted:	December 13, 2010
Last Verified:	December 2010

Keywords provided by Fonterra Research Centre:

Influenza; Prevention; Probiotic

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections	Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases