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

Improved Gut Health Outcomes Associated With Feihe Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula: A Randomized, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases; Gut Health
• Intervention / Treatment: Dietary supplement: Feihe Investigational Formula; Dietary supplement: Control Formula; Other: Breastfeeding

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China
      • Qiu Bin Community Hospital
    • Jinhua, Zhejiang, China
      • Jinhua Nanyuan Community Health Center
    • Jinhua, Zhejiang, China
      • Li Pu Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Newborn baby, study entry before weaning (within 28 days of birth)
• Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
• 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.) to 4200g (9 lbs. 4 oz.).
• 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 the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breastfeeding; breastmilk-feeding	Other: Breastfeeding; Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Experimental: Feihe Investigational Formula; 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; 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.
Active Comparator: Control Formula; Control formula contains comparable macronutrients and micronutrients, but does not contain probiotics fortified with hydrolyzed whey protein	Dietary supplement: Control Formula; 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Principal Investigator: Xiaoyang Sheng, MD, School of Medicine, Shanghai Jiaotong University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Prebiotics; Infant Formula; Hydrolyzed Whey Protein
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Lactation
• Other Study ID Numbers: 22-SM-11-FEIHE-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No