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

Not Applicable

Completed

• Conditions: Healthy Children
• Interventions: Dietary Supplement: a formula with prebiotics and milk fat

• Registration Number: NCT04864665
• Lead Sponsor: Danone Nutricia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-04-25
• Study First Posted: 2021-04-29
• Study Start: 2021-05-12
• Primary Completion: 2022-09-22
• Status Verified: 2023-10
• Study Completion: 2023-10-12
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Formula fed	a formula with prebiotics and milk fat	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)

Primary Outcome Measures

Name	Time	Method
Change in stool bifidobacteria level	32 days	Stool sample analysis

Secondary Outcome Measures

Name	Time	Method
Change in gastrointestinal tolerance	32 days	Parent reported questionnaire
Satisfaction with the study product	32 days	Parent reported questionnaire
Change in stool characteristics	32 days	• Stool image analysis based on the 4-point Brussels Infant and Toddler Stool Scale (watery, loose, formed, hard, with hard stools indicating worse outcome)
Change in stool lactobacillus level	32 days	Stool sample analysis

Trial Locations

Locations (6)

Ningbo Women and Children's Hospital; 🇨🇳 Ningbo, Zhejiang, China

Chengdu Women's and Children's Central Hospital; 🇨🇳 Chengdu, Sichuan, China

Beijing Children's Hospital of Capital Medical University; 🇨🇳 Beijing, China

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