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

NCT04864665 | Completed

• 1 other identifier: SBB0E_34098
• Study Type: interventional
• Target: 455
• Locations: 1 country
• Sites: 6

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

Keywords

Prebiotics; Gut microbiota; Formula

Outcome Measures

Primary Outcomes (1)

• Change in stool bifidobacteria level

  Stool sample analysis

  32 days

Secondary Outcomes (4)

• Change in stool lactobacillus level

  32 days

• Change in stool characteristics

  32 days

• Change in gastrointestinal tolerance

  32 days

• Satisfaction with the study product

  32 days

Study Arms (1)

Formula fed

EXPERIMENTAL

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

Interventions

a formula with prebiotics and milk fat DIETARY_SUPPLEMENT

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

Formula fed

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• SD);
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Nutricia: lead
• Nutricia Early Life Nutrition (Shanghai) Co., Ltd: collaborator

Study Sites (6)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

Location

Zhengzhou Children's hospital of Henan Children's hospital

Zhengzhou, Henan, China

Location

Tangdu Hospital, The Fourth Military Medical University

Xi’an, Shanxi, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

Ningbo Women and Children's Hospital

Ningbo, Zhejiang, China

Location

Beijing Children's Hospital of Capital Medical University

Beijing, China

Location

MeSH Terms

Interventions

Prebiotics

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: interventional with breastfed reference group

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: May 12, 2021
• Primary Completion: September 22, 2022
• Study Completion: October 12, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)