Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
Primary Purpose
Influenza
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bifidobacterium lactis HN019
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Prevention, Probiotic
Eligibility 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
Sites / Locations
- Clinical Research of South FloridaRecruiting
- Remedica, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
B. lactis HN019
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Influenza infection
Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
Secondary Outcome Measures
Symptom duration
Symptom severity
Adverse event incidence
The proportion of subjects that reports at least one adverse event (regardless of cause) during the study
Full Information
NCT ID
NCT01258842
First Posted
December 9, 2010
Last Updated
December 10, 2010
Sponsor
Fonterra Research Centre
Collaborators
Danisco, Sprim Advanced Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01258842
Brief Title
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fonterra Research Centre
Collaborators
Danisco, Sprim Advanced Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Prevention, Probiotic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
426 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
B. lactis HN019
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium lactis HN019
Intervention Description
B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo sachet, consumed once per day for 12 weeks
Primary Outcome Measure Information:
Title
Influenza infection
Description
Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Symptom duration
Time Frame
12 weeks
Title
Symptom severity
Time Frame
12 weeks
Title
Adverse event incidence
Description
The proportion of subjects that reports at least one adverse event (regardless of cause) during the study
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tisha Golden
Email
tisha.golden@sprim.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Clerici, MD
Organizational Affiliation
Milano University Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilio Clementi
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Rosen, MD
Phone
305-445-5637
First Name & Middle Initial & Last Name & Degree
Jeffrey Rosen, MD
Facility Name
Remedica, LLC
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rica Stamatin, MD
Phone
248-650-7870
First Name & Middle Initial & Last Name & Degree
Rica Stamatin, MD
12. IPD Sharing Statement
Learn more about this trial
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
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