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

Launched by HEILONGJIANG FEIHE DAIRY CO. LTD. · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a special infant formula that contains Lactoferrin and Human Milk Oligosaccharides (HMO) can help improve the immune system of newborns. The researchers want to find out if babies who drink this formula are less likely to catch colds and the flu compared to those who are breastfed or given a standard formula. The study will involve 240 infants, and they will be randomly assigned to one of three groups: the special formula, a control formula, or breast milk. Each baby will participate for 12 months, with up to six visits to the study site for check-ups.

To be eligible for the trial, infants must be newborns (within 28 days of birth), exclusively fed formula for at least three days before the study starts, and have a healthy birth weight of at least 5 pounds and 8 ounces. Parents will need to give their consent for their baby's participation and agree not to enroll them in any other clinical studies during this time. Throughout the trial, researchers will monitor the babies’ health and track how often they get sick, helping to see if this new formula really makes a difference in their overall immunity and growth.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Newborn baby, study entry before weaning (within 28 days of birth)
• • Exclusively formula for at least 3 days fed prior to onset of study period.
• • 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.) or more.
• • 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 Criteria:
• • 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 and during the study.