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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 Intervention Model: Parallel Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot

U.S. FDA Resources

Further study details as provided by Fonterra Research Centre:

Primary Outcome Measures:

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:

Symptom duration [ Time Frame: 12 weeks ]
Symptom severity [ Time Frame: 12 weeks ]
Adverse event incidence [ Time Frame: 12 weeks ]
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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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 August 16, 2017

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