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

NCT06159088 | Completed

• 1 other identifier: 22-SM-11-FEIHE-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Gut Health; Gastrointestinal Diseases

Keywords

Infant Formula; Prebiotics; Hydrolyzed Whey Protein

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Stool Consistency

  At the age of 15-28 days and 3, 6, 9, 12 months

• Weight in grams

  At the age of 15-28 days and 3, 6, 9, 12 months

• Height in cm

  At the age of 15-28 days and 3, 6, 9, 12 months

• Head circumference in cm

  At the age of 15-28 days and 3, 6, 9, 12 months

• Amount of formula intake in ml

  At the age of 15-28 days and 3, 6, 9, 12 months

Study Arms (3)

Feihe Investigational Formula

EXPERIMENTAL

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

Dietary Supplement: Feihe Investigational Formula

Control Formula

ACTIVE COMPARATOR

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

Dietary Supplement: Control Formula

Breastfeeding

OTHER

breastmilk-feeding

Other: Breastfeeding

Interventions

Feihe Investigational Formula DIETARY_SUPPLEMENT

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.

Feihe Investigational Formula

Control Formula DIETARY_SUPPLEMENT

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.

Control Formula

Breastfeeding OTHER

Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Breastfeeding

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang Feihe Dairy Co. Ltd.: lead

Study Sites (3)

Jinhua Nanyuan Community Health Center

Jinhua, Zhejiang, China

Location

Li Pu Community Hospital

Jinhua, Zhejiang, China

Location

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Lactation

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Xiaoyang Sheng, MD

  School of Medicine, Shanghai Jiaotong University, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two arms of participants will be assigned masked products (investigational formula and control formula) after randomization, while the participants of breastfeeding arm will not be assigned study products.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 6, 2023
• Study Start: November 14, 2023
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)