Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01258842 |
Recruitment Status
: Unknown
Verified December 2010 by Fonterra Research Centre.
Recruitment status was: Recruiting
First Posted
: December 13, 2010
Last Update Posted
: December 13, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Dietary Supplement: Bifidobacterium lactis HN019 Dietary Supplement: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 426 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 Start Date : | December 2010 |
Estimated Primary Completion Date : | May 2011 |
Estimated Study Completion Date : | May 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: B. lactis HN019 |
Dietary Supplement: Bifidobacterium lactis HN019
B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
|
Placebo Comparator: Placebo |
Dietary Supplement: Placebo
Placebo sachet, consumed once per day for 12 weeks
|
- Influenza infection [ Time Frame: 12 weeks ]Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
- Symptom duration [ Time Frame: 12 weeks ]
- Symptom severity [ Time Frame: 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258842
Contact: Tisha Golden | tisha.golden@sprim.com |
United States, Florida | |
Clinical Research of South Florida | Recruiting |
Coral Gables, Florida, United States, 33134 | |
Contact: Jeffrey Rosen, MD 305-445-5637 | |
Principal Investigator: Jeffrey Rosen, MD | |
United States, Michigan | |
Remedica, LLC | Recruiting |
Rochester, Michigan, United States, 48307 | |
Contact: Rica Stamatin, MD 248-650-7870 | |
Principal Investigator: Rica Stamatin, MD |
Principal Investigator: | Mario Clerici, MD | Milano University Medical School | |
Principal Investigator: | Emilio Clementi | University of Milan |
Responsible Party: | Pramod Gopral, PhD, Fonterra Research Centre |
ClinicalTrials.gov Identifier: | NCT01258842 History of Changes |
Other Study ID Numbers: |
10-SBUS-6-FON-02 |
First Posted: | December 13, 2010 Key Record Dates |
Last Update Posted: | December 13, 2010 |
Last Verified: | December 2010 |
Keywords provided by Fonterra Research Centre:
Influenza Prevention Probiotic |
Additional relevant MeSH terms:
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |