A Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Impact of Lactoferrin Dietary Supplementation on Respiratory Tract Infections in an Elderly Population

Mead Johnson Nutrition1 site in 1 country76 target enrollmentFebruary 8, 2021

ConditionsImmune Health

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immune Health
Sponsor: Mead Johnson Nutrition
Enrollment: 76
Locations: 1
Primary Endpoint: Number of Respiratory Tract Infections
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2021

End Date

April 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged ≥ 55 years of age at time of consent
•Able to eat and drink, with assistance if required
•Investigator and Community Living Center administration expect subject to reside in Community Living Center for the duration of the study
•Signed consent obtained from subject or legally authorized representative
•Signed authorization obtained to use and/or disclose Protected Health Information

Exclusion Criteria

•Receiving (or, in the opinion of the Investigator, likely to receive in the next 6 months) parenteral nutrition
•Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation
•Has been diagnosed as immunocompromised or is receiving medication which may cause immune compromise. Note relative immunocompromisation due to age would not exclude the subject
•Known allergy or intolerance to study products
•On an end-of-life care pathway or, in the opinion of the Investigator, has a life expectancy of less than 6 months
•Inappropriate for inclusion in the study in the opinion of the Investigator or Community Living Center administration
•Have experienced Respiratory Tract Infection within 1 week prior to randomization

Outcomes

Primary Outcomes

Number of Respiratory Tract Infections

Time Frame: 365 days

Secondary Outcomes

Comprehensive Metabolic Panel(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)
COVID Vaccine specific inflammatory panel(Day 45, Day 90, Day 180, Day 270, and Day 365)
Complications from Respiratory Tract Infections(365 days)
Duration of Respiratory Tract Infection(365 days)
Number of Respiratory Tract Infections(180 days)
Salivary level of thiocyanate(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
Microorganism causing Respiratory Tract Infection(365 days)
Salivary level of lactoferrin(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)
Influenza Hemagglutination-inhibition Antibody Titer(Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28)
Severity of Respiratory Tract Infection(365 days)
Inflammatory cytokine(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
Body Weight(Baseline, Day 45, Day 90, Day 180, and Day 365)
Treatment of Respiratory Tract Infections(365 days)
Level of protective antibody against influenza virus(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)
Use of medical treatments(365 days)
Cytokine Panel(Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28)
Protection against apoptosis and oxidative stress(Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365)
Medically confirmed Adverse Events(365 days)