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Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula

Flu Clinical Trial

Official title:
A Randomized, Controlled Trial of Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula

Clinical Trial Summary

The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is: - whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms. 240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting. Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing Lactoferrin fortified with HMO will improve immunity in newly born infants, along with physical development.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06158659
Study type Interventional
Source Heilongjiang Feihe Dairy Co. Ltd.
Contact Charlie Zhang, MD
Phone +8613901981272
Email charlie.zhang@sprimmedical.com
Status Recruiting
Phase N/A
Start date November 14, 2023
Completion date April 30, 2025
View Details
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