Clinical trial NCT06159088: Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula
Official title: A Randomized, Controlled Trial of Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gut Health
Gastrointestinal Diseases
Keywords: Infant Formula
Prebiotics
Hydrolyzed Whey Protein
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 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.


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: Stool Frequency
timeFrame: At the end of 12 months
Secondary outcomes:
measure: Stool Consistency
timeFrame: At the age of 15-28 days and 3, 6, 9, 12 months
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: 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: