Clinical trial NCT06158659: Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
Official title: A Randomized, Controlled Trial of Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flu
Cold
Keywords: infant formula
lactoferrin
HMO (Human Milk Oligosaccharides)
immunology
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Frequency of flu and cold during the study
timeFrame: At the age of 12 months
Secondary outcomes:
measure: Weight in grams
timeFrame: At the age of 15-28 days and 3, 6, 9, 12 months]
measure: Height in cm
timeFrame: At the age of 15-28 days and 3, 6, 9, 12 months
measure: Head circumference in cm
timeFrame: At the age of 15-28 days and 3, 6, 9, 12 months
measure: Amount of formula intake in ml
timeFrame: At the age of 15-28 days and 3, 6, 9, 12 months
measure: Stool Characteristics Questionnaire
timeFrame: At the age of 15-28 days and 3, 6 months
measure: Medically-confirmed adverse events
timeFrame: baseline day to 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Kaitai Scientific Lab
state: Zhejiang
Study officials:
affiliation: SPRIM Medical
name: Charlie Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: