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

Healthy Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864665
• Other study ID #: SBB0E_34098
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: October 12, 2023

Study information

• Verified date: October 2023
• Source: Danone Nutricia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 455
• Est. completion date: October 12, 2023
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Children

Intervention

Dietary Supplement:
• a formula with prebiotics and milk fat
Provided in a formula added with prebiotics and milk fat for 1 month

Locations

Country	Name	City	State
China	Beijing Children's Hospital of Capital Medical University	Beijing
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	Guangzhou Women and Children's Medical Center	Guangzhou	Guangdong
China	Ningbo Women and Children's Hospital	Ningbo	Zhejiang
China	Tangdu Hospital, The Fourth Military Medical University	Xi'an	Shanxi
China	Zhengzhou Children's hospital of Henan Children's hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Danone Nutricia	Nutricia Early Life Nutrition (Shanghai) Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool bifidobacteria level	Stool sample analysis	32 days
Secondary	Change in stool lactobacillus level	Stool sample analysis	32 days
Secondary	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
Secondary	Change in gastrointestinal tolerance	Parent reported questionnaire	32 days
Secondary	Satisfaction with the study product	Parent reported questionnaire	32 days