Healthy ChildrenNCT04864665
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
A study testing a formula with prebiotics and milk fat in people with Healthy Children, run by Danone Nutricia at 6 sites in China.
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. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- a formula with prebiotics and milk fat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 6 sitesChina
- Study dates
- 12 May 2021to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Children's Hospital of Capital Medical University
Beijing
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
Ningbo Women and Children's Hospital
Ningbo, Zhejiang
Tangdu Hospital, The Fourth Military Medical University
Xi’an, Shanxi
Zhengzhou Children's hospital of Henan Children's hospital
Zhengzhou, Henan
About this study
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
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
- Being tested
- a formula with prebiotics and milk fat
- Keywords
- Prebiotics, Gut microbiota, Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a formula with prebiotics and milk fatDietary supplement
Provided in a formula added with prebiotics and milk fat for 1 month
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: a formula with prebiotics and milk fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool bifidobacteria level
Stool sample analysis
Measured: 32 days
Secondary outcomes (4)
Change in stool lactobacillus level
Stool sample analysis
Measured: 32 days
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)
Measured: 32 days
Change in gastrointestinal tolerance
Parent reported questionnaire
Measured: 32 days
Satisfaction with the study product
Parent reported questionnaire
Measured: 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start12 May 2021
- Primary completion22 Sep 2022
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional with breastfed reference group
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Nutricia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Early Life Nutrition (Shanghai) Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864665
- Sponsor's protocol ID
- SBB0E_34098
- Status last verified
- Oct 2023
- First submitted
- 25 Apr 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04864665
- Acronym / sponsor ID
- SBB0E_34098
- Conditions
- Healthy Children
- Keywords
- Prebiotics, Gut microbiota, Formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Collaborators
- Nutricia Early Life Nutrition (Shanghai) Co., Ltd
- Study start
- 12 May 2021 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional with breastfed reference group
| Arm | Type | Receives |
|---|---|---|
| Formula fed | Experimental | Dietary Supplement: a formula with prebiotics and milk fat0 - 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) |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
- No relocation across provinces/ cities in the past 1 year and no plans to relocate during the study period.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a formula with prebiotics and milk fatProvided in a formula added with prebiotics and milk fat for 1 month | Dietary supplement | Formula fed |
Primary outcome
Change in stool bifidobacteria level
Time frame: 32 days
Stool sample analysis
4 secondary outcomes
Change in stool lactobacillus level
Time frame: 32 days
Change in stool characteristics
Time frame: 32 days
Change in gastrointestinal tolerance
Time frame: 32 days
Satisfaction with the study product
Time frame: 32 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a formula with prebiotics and milk fat in people with Healthy Children, run by Danone Nutricia at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool bifidobacteria level (time frame: 32 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.