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

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

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.

Study Overview

• Status: Unknown
• Conditions: Influenza
• Intervention / Treatment: Dietary supplement: Bifidobacterium lactis HN019; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 426
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tisha Golden; Email: tisha.golden@sprim.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Placebo sachet, consumed once per day for 12 weeks
EXPERIMENTAL: B. lactis HN019	Dietary supplement: Bifidobacterium lactis HN019; B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fonterra Research Centre
• Collaborators: Sprim Advanced Life Sciences; Danisco
• Investigators: Principal Investigator: Mario Clerici, MD, Milano University Medical School; Principal Investigator: Emilio Clementi, University of Milan

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ANTICIPATED): May 1, 2011
• Study Completion (ANTICIPATED): May 1, 2011

Study Registration Dates

• First Submitted: December 9, 2010
• First Submitted That Met QC Criteria: December 10, 2010
• First Posted (ESTIMATE): December 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Influenza; Prevention; Probiotic
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 10-SBUS-6-FON-02