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

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 Overview

• Status: Completed
• Conditions: Healthy Children
• Intervention / Treatment: Dietary supplement: a formula with prebiotics and milk fat

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mengjin LIU; Phone Number: +86-21-61798888; Email: register.clinicalresearchnutriciaCN@danone.com

Study Locations

• China
  • Beijing, China
    • Beijing Children's Hospital of Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangzhou Women and Children's Medical Center
  • Henan
    • Zhengzhou, Henan, China
      • Zhengzhou Children's hospital of Henan Children's hospital
  • Shanxi
    • Xi'an, Shanxi, China
      • Tangdu Hospital, The Fourth Military Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Women's and Children's central hospital
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Ningbo Women And Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The gestational age was 37-42 weeks at birth;
• Birth weight ≥2,500 g and ≤ 4,500 g;
• Chinese nationality;

• Weight and height are within normal range (i.e. WHO Child Growth Standards

  • 2SD);
• No relocation across provinces/ cities in the past 1 year and no plans to relocate during the study period.
• Breastfeeding reference: breastfeeding at the time of enrollment, and the mother intends to continue breastfeeding throughout the study period;
• Intervention arm: formula feeding / habitual milk drinking (formula milk, milk and other dairy products) at the time of enrollment, and willing to change from the original milk powder / dairy product to the study formula, and consume it as instructed during the study period;
• The child's parent(s) / guardian has access to a mobile phone on which the secure digital WeChat platform can be installed and used, connect to the network, take photographs and record defecation, and complete questionnaires during the study;
• The child's parent(s) / guardian is of legal age of consent, has sufficient command of Chinese (Mandarin) language to complete the informed consent and other study documents, is willing and able to fulfill the requirements of the study.
• The child's parent(s) / guardians can be contacted directly by telephone or WeChat;

Exclusion Criteria:

• Neonatal asphyxia at birth;
• Chronic infectious, metabolic, genetic illness or other disease including any condition that impacts feeding or may impact study outcomes;
• Cognitive and developmental disorders;
• Antibiotic usage up to 2 weeks before enrollment;
• Ongoing antibiotic treatment;
• Taking probiotic supplements or formula with probiotics up to 1 month before enrollment;
• Participation in other clinical trials;
• Parent(s)' / guardian's refusal to participate in the study;
• Known or suspected allergy to cow milk, soy or fish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Formula fed; 0 - 6 months: a formula with prebiotics and milk fat (Stage 1); >6 - 12 months: a formula with prebiotics and milk fat (Stage 2); >1 - 2 years: a formula with prebiotics and milk fat (Stage 3)	Dietary supplement: a formula with prebiotics and milk fat; Provided in a formula added with prebiotics and milk fat for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stool bifidobacteria level	Stool sample analysis	32 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stool lactobacillus level	Stool sample analysis	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)	32 days
Change in gastrointestinal tolerance	Parent reported questionnaire	32 days
Satisfaction with the study product	Parent reported questionnaire	32 days

Collaborators and Investigators

• Sponsor: Danone Nutricia
• Collaborators: Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Gut microbiota; Formula; Prebiotics
• Other Study ID Numbers: SBB0E_34098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No