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

NCT06159088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

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.

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.

OTHER

Breastfeeding

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

Sponsors & Collaborators

  • Heilongjiang Feihe Dairy Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoyang Sheng, MD · School of Medicine, Shanghai Jiaotong University, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-14
Primary Completion
2025-04-03
Completion
2025-04-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06159088 on ClinicalTrials.gov