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This is a randomized, double-blind, placebo-controlled study to evaluate the impact of bovine Lactoferrin (bLf) on respiratory tract infections (RTIs) in an elderly population in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Placebo | Placebo Comparator | Control: Placebo |
|
| Investigational: 600 mg bovine lactoferrin supplement | Experimental | Investigational: 600 mg bovine lactoferrin supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control: Placebo | Dietary Supplement | Placebo |
| |
| bovine lactoferrin supplement |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Respiratory Tract Infections | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Respiratory Tract Infection | Mild, Moderate, or Severe rating | 365 days |
| Duration of Respiratory Tract Infection | 365 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Wu, MD | Mead Johnson/RB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
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| Dietary Supplement |
600 mg |
|
| Number of Respiratory Tract Infections |
| 180 days |
| Treatment of Respiratory Tract Infections | 365 days |
| Complications from Respiratory Tract Infections | 365 days |
| Microorganism causing Respiratory Tract Infection | 365 days |
| Level of protective antibody against influenza virus | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Inflammatory cytokine | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Protection against apoptosis and oxidative stress | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Salivary level of lactoferrin | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Salivary level of thiocyanate | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Salivary level of hypohalous acid | Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Complete Blood Count | Baseline, Day 45, Day 90, Day 180, and Day 365 |
| Comprehensive Metabolic Panel | Baseline, Day 45, Day 90, Day 180, and Day 365 |
| Body Weight | Baseline, Day 45, Day 90, Day 180, and Day 365 |
| Short Form (12) Health Survey Version 2 (SF-12v2®) | Baseline, Day 45, Day 90, Day 180, and Day 365 |
| Use of medical treatments | 365 days |
| Medically confirmed Adverse Events | 365 days |
| COVID Vaccine specific inflammatory panel | IGG concentrations and geometric means of SARS psuedovirus neutralization titers and Cytokines | Day 45, Day 90, Day 180, Day 270, and Day 365 |
| Influenza Hemagglutination-inhibition Antibody Titer | Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 |
| Cytokine Panel | Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28 |