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Probiotic
Bifidobacterium Lactis HN019 Supplementation for Prevention of Influenza Infection in Healthy Adults
Phase 3
Waitlist Available
Led By Mario Clerici, MD
Research Sponsored by Fonterra Research Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal 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.
Eligible Conditions
- Influenza
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Influenza infection
Secondary study objectives
Adverse event incidence
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: B. lactis HN019Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bifidobacterium lactis HN019
2009
Completed Phase 3
~100
Find a Location
Who is running the clinical trial?
Fonterra Research CentreLead Sponsor
8 Previous Clinical Trials
908 Total Patients Enrolled
DaniscoIndustry Sponsor
34 Previous Clinical Trials
3,169 Total Patients Enrolled
Sprim Advanced Life SciencesOTHER
34 Previous Clinical Trials
5,183 Total Patients Enrolled
Mario Clerici, MDPrincipal InvestigatorMilano University Medical School
Emilio ClementiPrincipal InvestigatorUniversity of Milan
1 Previous Clinical Trials
12 Total Patients Enrolled