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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04713735
Other study ID # 3393-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2021
Est. completion date April 28, 2023

Study information

Verified date March 2023
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date April 28, 2023
Est. primary completion date February 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Control: Placebo
Placebo
bovine lactoferrin supplement
600 mg

Locations

Country Name City State
United States VA Greater Los Angeles Healthcare System Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Respiratory Tract Infections 365 days
Secondary Severity of Respiratory Tract Infection Mild, Moderate, or Severe rating 365 days
Secondary Duration of Respiratory Tract Infection 365 days
Secondary Number of Respiratory Tract Infections 180 days
Secondary Treatment of Respiratory Tract Infections 365 days
Secondary Complications from Respiratory Tract Infections 365 days
Secondary Microorganism causing Respiratory Tract Infection 365 days
Secondary Level of protective antibody against influenza virus Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Inflammatory cytokine Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Protection against apoptosis and oxidative stress Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Salivary level of lactoferrin Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Salivary level of thiocyanate Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Salivary level of hypohalous acid Baseline, Day 45, Day 90, Day 180, Day 270, and Day 365
Secondary Complete Blood Count Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary Comprehensive Metabolic Panel Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary Body Weight Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary Short Form (12) Health Survey Version 2 (SF-12v2®) Baseline, Day 45, Day 90, Day 180, and Day 365
Secondary Use of medical treatments 365 days
Secondary Medically confirmed Adverse Events 365 days
Secondary 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
Secondary Influenza Hemagglutination-inhibition Antibody Titer Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
Secondary Cytokine Panel Pre-booster, Post-booster day 2, Post-booster day 7, and Post-booster day 28
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