NCT06159088

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Heilongjiang Feihe Dairy Co. Ltd. · Industry
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2023-12-06
• Last updated: 2025-12-08

Locations

3 sites across 1 country: China