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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
455
Provided in a formula added with prebiotics and milk fat for 1 month
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Zhengzhou Children's hospital of Henan Children's hospital
Zhengzhou, Henan, China
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China
Beijing Children's Hospital of Capital Medical University
Beijing, China
Change in stool bifidobacteria level
Stool sample analysis
Time frame: 32 days
Change in stool lactobacillus level
Stool sample analysis
Time frame: 32 days
Change in stool characteristics
• Stool image analysis based on the 4-point Brussels Infant and Toddler Stool Scale (watery, loose, formed, hard, with hard stools indicating worse outcome)
Time frame: 32 days
Change in gastrointestinal tolerance
Parent reported questionnaire
Time frame: 32 days
Satisfaction with the study product
Parent reported questionnaire
Time frame: 32 days
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