Clinical trial NCT04864665: Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Keywords: Prebiotics
Gut microbiota
Formula
Lead sponsor: Danone Nutricia
Sponsor class: INDUSTRY
Collaborators: name: Nutricia Early Life Nutrition (Shanghai) Co., Ltd
First posted: 2021-04-29
Enrollment: 455
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional with breastfed reference group
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in stool bifidobacteria level
timeFrame: 32 days
Secondary outcomes:
measure: Change in stool lactobacillus level
timeFrame: 32 days
measure: Change in stool characteristics
timeFrame: 32 days
measure: Change in gastrointestinal tolerance
timeFrame: 32 days
measure: Satisfaction with the study product
timeFrame: 32 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
city: Zhengzhou
country: China
facility: Zhengzhou Children's hospital of Henan Children's hospital
state: Henan
city: Xi'an
country: China
facility: Tangdu Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital of Capital Medical University
Study officials:
References: