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

NCT ID: NCT04864665

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 455 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2023-10-12

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.

Conditions

Healthy Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

a formula with prebiotics and milk fat

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

a formula with prebiotics and milk fat

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Early Life Nutrition (Shanghai) Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Danone Nutricia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

SBB0E_34098

Identifier Type: -

Identifier Source: org_study_id