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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01258842
• Other study ID #: 10-SBUS-6-FON-02
• Status: Recruiting
• Phase: Phase 3
• First received: December 9, 2010
• Last updated: December 10, 2010
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: December 2010
• Source: Fonterra Research Centre
• Contact: Tisha Golden
• Email: tisha.golden[@]sprim.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 426
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Dietary Supplement:
• Bifidobacterium lactis HN019
B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
• Placebo
Placebo sachet, consumed once per day for 12 weeks

Locations

Country	Name	City	State
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Remedica, LLC	Rochester	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Fonterra Research Centre	Danisco, Sprim Advanced Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza infection	Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period	12 weeks	No
Secondary	Symptom duration		12 weeks	No
Secondary	Symptom severity		12 weeks	No
Secondary	Adverse event incidence	The proportion of subjects that reports at least one adverse event (regardless of cause) during the study	12 weeks	Yes