Recruiting
Phase 3

Bifidobacterium Lactis

Sponsor:

Fonterra Research Centre

Code:

NCT01258842

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Bifidobacterium lactis HN019

Placebo

Study Details

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.

Conditions

Influenza

Study ID

NCT01258842

Start date

Dec, 2010

Status verified date

Dec, 2010

Completion date

May, 2011

Anticipated

Primary completion date

May, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Enrollment

426 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: B. lactis HN019

placebo comparator: Placebo

Interventions

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

Primary outcome measure

  • Influenza infection [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Tisha Golden

tisha.golden@sprim.com

Locations

Clinical Research of South Florida

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Jeffrey Rosen, MD

305-445-5637

Principal Investigator:

Jeffrey Rosen, MD

Remedica, LLC

Recruiting

Rochester, Michigan, United States, 48307

Contacts

Rica Stamatin, MD

248-650-7870

Principal Investigator:

Rica Stamatin, MD

More Information

Sponsor

Fonterra Research Centre

Last update posted

Dec 13, 2010

Last verified

Dec, 2010

Keywords

  • Influenza
  • Prevention
  • Probiotic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Fonterra Research Centre on 2010-12-13.