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

NCT04864665 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2023-10-31

No results posted yet for this study

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

DIETARY_SUPPLEMENT

a formula with prebiotics and milk fat

Provided in a formula added with prebiotics and milk fat for 1 month

Sponsors & Collaborators

  • Nutricia Early Life Nutrition (Shanghai) Co., Ltd

    collaborator UNKNOWN

  • Danone Nutricia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2022-09-22
Completion
2023-10-12

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 NCT04864665 on ClinicalTrials.gov