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| Name | Class |
|---|---|
| Danisco | INDUSTRY |
| Sprim Advanced Life Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B. lactis HN019 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifidobacterium lactis HN019 | Dietary Supplement | B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Influenza infection | Incidence of physician- and laboratory-confirmed influenza infection at any time during the 12-week supplementation period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom duration | 12 weeks | |
| Symptom severity | 12 weeks | |
| Adverse event incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tisha Golden | Contact | tisha.golden@sprim.com |
| Name | Affiliation | Role |
|---|---|---|
| Mario Clerici, MD | Milano University Medical School | Principal Investigator |
| Emilio Clementi | University of Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research of South Florida | Recruiting | Coral Gables | Florida | 33134 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Dietary Supplement | Placebo sachet, consumed once per day for 12 weeks |
|
The proportion of subjects that reports at least one adverse event (regardless of cause) during the study
| 12 weeks |
| Remedica, LLC | Recruiting | Rochester | Michigan | 48307 | United States |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |