Impact of Lactoferrin, a Dietary Supplement, vs. Placebo on Respiratory Tract Infections

Mead Johnson Nutrition

Status

Completed

Conditions

Immune Health

Treatments

Dietary Supplement: bovine lactoferrin supplement

Dietary Supplement: Control: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04713735

3393-1

Details and patient eligibility

About

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.

Enrollment

76 patients

Sex

All

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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