Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Fonterra Research Centre.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fonterra Research Centre
Collaborators:
Danisco
Sprim Advanced Life Sciences
Information provided by:
Fonterra Research Centre
ClinicalTrials.gov Identifier:
NCT01258842
First received: December 9, 2010
Last updated: December 10, 2010
Last verified: December 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Dietary Supplement: Bifidobacterium lactis HN019 Dietary Supplement: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Fonterra Research Centre:
Primary Outcome Measures:
- Influenza infection [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period
Secondary Outcome Measures:
- Symptom duration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Symptom severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Adverse event incidence [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The proportion of subjects that reports at least one adverse event (regardless of cause) during the study
| Estimated Enrollment: | 426 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258842
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258842
Contacts
| Contact: Tisha Golden | tisha.golden@sprim.com |
Locations
| 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 | |
Sponsors and Collaborators
Fonterra Research Centre
Danisco
Sprim Advanced Life Sciences
Investigators
| Principal Investigator: | Mario Clerici, MD | Milano University Medical School |
| Principal Investigator: | Emilio Clementi | University of Milan |
More Information
| Responsible Party: | Pramod Gopral, PhD, Fonterra Research Centre |
| ClinicalTrials.gov Identifier: | NCT01258842 History of Changes |
| Other Study ID Numbers: | 10-SBUS-6-FON-02 |
| Study First Received: | December 9, 2010 |
| Last Updated: | December 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 30, 2016