Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula

China Feihe

Status

Enrolling

Conditions

Gastrointestinal Diseases

Gut Health

Treatments

Other: Breastfeeding

Dietary Supplement: Feihe Investigational Formula

Dietary Supplement: Control Formula

Study type

Interventional

Funder types

Industry

Identifiers

NCT06159088

22-SM-11-FEIHE-003

Details and patient eligibility

About

The goal of this interventional clinical trial is to test the effectiveness of improving gut health in terms of frequency of bowel movements in newly born infants fed with Feihe investigational formula product containing probiotics fortified with hydrolyzed hey protein. The main question it aims to answer is:

whether the frequency of bowel movements (through 12 months) of participants 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 bowel movements through 12 months, 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 probiotics fortified with hydrolyzed hey protein will improve gut health in newly born infants, along with physical development.

Enrollment

240 estimated patients

Sex

All

Ages

1 to 28 days old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 3 patient groups

Feihe Investigational Formula

Experimental group

Description:

Feihe Investigational Formula 1. With the highest probiotic content 2. Containing 2' -fucosyl lactose 3. Add hydrolyzed whey protein 4. Comprehensive nutrition: OPO, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein

Treatment:

Dietary Supplement: Feihe Investigational Formula

Control Formula

Active Comparator group

Description:

Control formula contains comparable macronutrients and micronutrients, but does not contain probiotics fortified with hydrolyzed whey protein

Treatment:

Dietary Supplement: Control Formula

Breastfeeding

Other group

Description:

breastmilk-feeding