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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
Fonterra Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Prevention, Probiotic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 9, 2010
Last Updated
December 10, 2010
Sponsor
Fonterra Research Centre
Collaborators
Danisco, Sprim Advanced Life Sciences
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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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