NCT04864665

Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children

A Prospective, Multicentre Before and After Study to Evaluate the Effects of a Formula With Prebiotics and Milk Fat, on the Gut Health of Chinese Infants and Young Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Danone Nutricia · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood. It can inhibit the growth of pathogenic bacteria, prevent the occurrence of diseases and improve the child's quality of life. It is therefore important to regulate the microbiota balance in infants and young children. This objective of this post-launch study is to evaluate the effects of a formula with prebiotics and milk fat on the gut microbiota and stool characteristics of healthy Chinese infants and young children. The duration of the study for each participant is 32 days and includes 3 study visits.

Conditions

• Healthy Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	a formula with prebiotics and milk fat	Provided in a formula added with prebiotics and milk fat for 1 month

Timeline

• Start date: 2021-05-12
• Primary completion: 2022-09-22
• Completion: 2023-10-12
• First posted: 2021-04-29
• Last updated: 2023-10-31

Locations

6 sites across 1 country: China