- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258842
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
December 10, 2010 updated by: Fonterra Research Centre
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
426
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tisha Golden
- Email: tisha.golden@sprim.com
Study Locations
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Placebo sachet, consumed once per day for 12 weeks
|
EXPERIMENTAL: B. 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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
12 weeks
|
|
Symptom severity
Time Frame: 12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mario Clerici, MD, Milano University Medical School
- Principal Investigator: Emilio Clementi, University of Milan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-SBUS-6-FON-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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