Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-27 @ 6:19 AM
Study NCT ID:
NCT06158659
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2023-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Organization:
Study Overview
Official Title:
Improved Immunology Outcomes Associated With Feihe Lactoferrin Fortified With HMO in Infant Formula: A Randomized, Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
\- 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: