Status:
COMPLETED
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
Lead Sponsor:
Heilongjiang Feihe Dairy Co. Ltd.
Conditions:
Flu
Cold
Eligibility:
All Genders
1-28 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Newborn baby, study entry before weaning (within 28 days of birth)
- Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
- Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
- Signed informed consent obtained for infant's participation in the study.
- Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.
Exclusion
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
- Evidence of growth problems or concern for growth.
- Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
- Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
- Use of probiotics/prebiotics before the study.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06158659
Start Date
November 14 2023
End Date
April 3 2025
Last Update
December 8 2025
Active Locations (3)
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1
Jinhua Nanyuan Community Health Center
Jinhua, Zhejiang, China
2
Li Pu Community Hospital
Jinhua, Zhejiang, China
3
Qiu Bin Community Hospital
Jinhua, Zhejiang, China