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

NCT04713735

CompletedNA

Sponsor: Mead Johnson Nutrition

Conditions: Immune Health

Interventions: Control: Placebo, bovine lactoferrin supplement

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 55 Years to

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (1)
  • Los Angeles, California, United States