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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Controlled Trial of Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula

Conditions
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Gut Health, Gastrointestinal Diseases

Intervention / Treatment
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* Dietary Supplement: Feihe Investigational Formula
* Dietary Supplement: Control Formula
* Other: Breastfeeding


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feihe Investigational Formula<br>Feihe Investigational Formula With the highest probiotic content Containing 2' -fucosyl lactose Add hydrolyzed whey protein Comprehensive nutrition: OPO, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein | Dietary Supplement: Feihe Investigational Formula<br>* Participants in this arm will receive stage 1 and stage 2 Feihe investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.<br>|
| Active Comparator: Control Formula<br>Control formula contains comparable macronutrients and micronutrients, but does not contain probiotics fortified with hydrolyzed whey protein | Dietary Supplement: Control Formula<br>* Participants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.<br>|
| Other: Breastfeeding<br>breastmilk-feeding | Other: Breastfeeding<br>* Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Frequency | counting number of bowel movements per week, and adds together at the end of the study | At the end of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool Consistency | The rating score (0-5) of the stool consistency over the 24-hour period. The rating score of the stool consistency from the stool picture: 0-No bowel movement; Hard- dry, hard pellets; Formed- definite shape, not dry; Soft-no definite shape, pasty; Unformed or seedy- no shape, some water or small lumps ; Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics. | At the age of 15-28 days and 3, 6, 9, 12 months | 
| Weight in grams | The weight measurement (gram) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months | 
| Height in cm | The height measurement (cm) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months | 
| Head circumference in cm | The head circumference measurement (cm) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months | 
| Amount of formula intake in ml | The 24-Hour dietary recall of Formula intake (amount in ml of study formula, any other infant formula or milk consumed) of the participant for each site visit | At the age of 15-28 days and 3, 6, 9, 12 months | 
| Medically-confirmed adverse events | The frequency of medically-confirmed adverse events occurred during the study | baseline day to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Formula, Prebiotics, Hydrolyzed Whey Protein