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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fonterra Research Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Danisco
Sprim Advanced Life Sciences
Information provided by:
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01258842
First received: December 9, 2010
Last updated: December 10, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Influenza
 Dietary Supplement: Bifidobacterium lactis HN019
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:
  • Influenza infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period


Secondary Outcome Measures:
  • Symptom duration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Symptom severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse event incidence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The proportion of subjects that reports at least one adverse event (regardless of cause) during the study


Estimated Enrollment: 426
Study Start Date: December 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258842

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

No publications provided

Responsible Party: Pramod Gopral, PhD, Fonterra Research Centre
ClinicalTrials.gov Identifier: NCT01258842     History of Changes
Other Study ID Numbers: 10-SBUS-6-FON-02
Study First Received: December 9, 2010
Last Updated: December 10, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013