Healthy InfantsNCT03520764
To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants
A study testing New infant formula with synbiotics and Standard infant formula with prebiotics in people with Healthy Infants, run by Danone Nutricia at 6 sites in China.
Trial summary
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. Read more about this study
- Who is it for?
- Ages Up to 44 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- New infant formula with synbiotics and Standard infant formula with prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 6 sitesChina
- Study dates
- 3 Apr 2018to 9 Nov 2020
- 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 44 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Chinese term infants ≤ 44 days
- Birth weight within normal range
- Head circumference within normal range
- Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age
Who cannot join
- The mothers of infants:
- who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
- Parents/Legally acceptable representatives/Caregivers of infants:
- who are incapable to comply with study protocol
- Infants:
Show all 10Show fewer
- who have to be fed with a special diet other than standard cow's milk based infant formula;
- known to have current or previous illnesses/conditions which could interfere with the study products or its outcome parameters
- known or suspected to have an allergic condition towards cow's milk, soy or fish;
- with any history of, or current participation in any other study involving investigational or marketed products.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Peking University 3rd Hospital
Beijing, Beijing Municipality
Guangzhou women and Children's Medical Center
Guangzhou, Guangdong, 510623
Guangdong Province Maternal and Children Hospital
Guangzhou, Guangdong
Shanghai Public Health Clinical Research Center
Shanghai, Shanghai Municipality
Xin Hua Hospital
Shanghai, Shanghai Municipality
Wuxi Poeple's Hospital
Wuxi, Jiangsu
About this study
Official title: A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.
Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.
Read more
Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.
Safety, growth and tolerance parameters will be followed and collected throughout the study.
- Conditions
- Healthy Infants
- Being tested
- New infant formula with synbiotics, Standard infant formula with prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New infant formula with synbioticsDietary supplement
Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
Standard infant formula with prebioticsDietary supplement
Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.
| Study group | Role | What they receive |
|---|---|---|
| New infant formula with synbiotics | Experimental | pHP infant formula with synbiotics (test product) Receives: Dietary Supplement: New infant formula with synbiotics |
| Standard infant formula with prebiotics | Active comparator | Standard (commercial) infant formula with prebiotics (control product) Receives: Dietary Supplement: Standard infant formula with prebiotics |
| human milk | No intervention | Full breastfeeding for at least 17 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain per day from baseline (g/day)
Measured: at the age of 17 weeks
Secondary outcomes (13)
Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.
Measured: at the age of 17 weeks
Increment per day from baseline on length (mm/day)
Measured: at the age of 17 weeks
Increment per day from baseline on head circumference (mm/day)
Measured: at the age of 17 weeks
Increment per day from baseline on mid-upper arm circumference (mm/day)
Measured: at the age of 17 weeks
Z-scores of anthropometric parameters from baseline on weight
Measured: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on length
Measured: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on head circumference
Measured: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on mid-upper arm circumference
Measured: from baseline until the age of 17 weeks
Effect on incidence, frequency and severity of (serious) adverse events
Measured: from baseline until the age of 17 weeks
Parent-reported occurrence of diarrhea
Measured: from baseline until the age of 17 weeks
Parent-reported severity of diarrhea
Measured: from baseline until the age of 17 weeks
Parent-reported occurrence of constipation
Measured: from baseline until the age of 17 weeks
Parent-reported severity of constipation
Measured: from baseline until the age of 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start3 Apr 2018
- Primary completion6 Mar 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy InfantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 284 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
- NCT03520764
- Sponsor's protocol ID
- EBB16SI08406
- Status last verified
- Feb 2021
- First submitted
- 11 Mar 2018
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Wopereis H, Kakourou A, Liu M, Wu J, Li Z, Zhang L, Tan M, Low JSY, Liu M, Roeselers G, Knol J, Cai W. Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section. Eur J Clin Nutr. 2025 Jun;79(6):567-575. doi: 10.1038/s41430-025-01571-8. Epub 2025 Feb 6.
PubMed 39915586
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-blind Study to Investigate the Effects of a New Infant Formula on Growth, Safety, and Tolerance in Healthy Term Chinese Infants
- ClinicalTrials.gov ID
- NCT03520764
- Acronym / sponsor ID
- EBB16SI08406
- Conditions
- Healthy Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Danone NutriciaIndustry (pharma, biotech, devices)
- Collaborators
- Nutricia Early Life Nutrition (Shanghai) Co., Ltd
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 11 May 2018 (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.
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants.
Screening starts after the informed consent is obtained. Infants who are less than or equal to 44 days of age and meeting all eligibility criteria will be enrolled into the study. The total duration of the study is around 12 months which includes 8 study visits.
Infants, whose mother has the intention to fully breastfeed her infant at least until 17 weeks of age will be enrolled into the breastfeeding reference group. Infants, whose mother has the intention to fully formula feed her infant as of 44 days of age at the latest, will be randomized to receive either the investigational product or control product until infants reach the age of 17 weeks. After the age of 17 weeks, infants can switch to any feeding and continue be followed up until 12 months of age.
Safety, growth and tolerance parameters will be followed and collected throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Intervention group: New infant formula with synbiotics; Control group: Standard infant formula with prebiotics
| Arm | Type | Receives |
|---|---|---|
| New infant formula with synbiotics | Experimental | Dietary Supplement: New infant formula with synbioticspHP infant formula with synbiotics (test product) |
| Standard infant formula with prebiotics | Active comparator | Dietary Supplement: Standard infant formula with prebioticsStandard (commercial) infant formula with prebiotics (control product) |
| human milk | No intervention | –Full breastfeeding for at least 17 weeks |
Who may qualify
- Ages
- Up to 44 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy Chinese term infants ≤ 44 days
- Birth weight within normal range
- Head circumference within normal range
- Fully formula fed by the time of randomization OR fully breastfed and with intention to fully breastfeed until 17 weeks of age
Key exclusion criteria (10 listed)
- The mothers of infants:
- who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation;
- known to have a significant medical condition that might interfere with the study or known to affect intra-uterine growth, as per investigator's clinical judgement;
- who are incapable to comply with study protocol
- who have to be fed with a special diet other than standard cow's milk based infant formula;
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 |
|---|---|---|
| New infant formula with synbioticsInfants are fed with synbiotics formula for 17 weeks from the date of enrollment. | Dietary supplement | New infant formula with synbiotics |
| Standard infant formula with prebioticsInfants are fed with prebiotics formula for 17 weeks from the date of enrollment. | Dietary supplement | Standard infant formula with prebiotics |
Primary outcome
Weight gain per day from baseline (g/day)
Time frame: at the age of 17 weeks
13 secondary outcomes
Weight gain per day from baseline (g/day) in infant receiving test product compared to breastfed infant.
Time frame: at the age of 17 weeks
Increment per day from baseline on length (mm/day)
Time frame: at the age of 17 weeks
Increment per day from baseline on head circumference (mm/day)
Time frame: at the age of 17 weeks
Increment per day from baseline on mid-upper arm circumference (mm/day)
Time frame: at the age of 17 weeks
Z-scores of anthropometric parameters from baseline on weight
Time frame: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on length
Time frame: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on head circumference
Time frame: from baseline until the age of 17 weeks
Z-scores of anthropometric parameters from baseline on mid-upper arm circumference
Time frame: from baseline until the age of 17 weeks
Effect on incidence, frequency and severity of (serious) adverse events
Time frame: from baseline until the age of 17 weeks
Parent-reported occurrence of diarrhea
Time frame: from baseline until the age of 17 weeks
Parent-reported severity of diarrhea
Time frame: from baseline until the age of 17 weeks
Parent-reported occurrence of constipation
Time frame: from baseline until the age of 17 weeks
Parent-reported severity of constipation
Time frame: from baseline until the age of 17 weeks
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 26 Feb 2021.
- Derived from this study: PubMed 39915586Wang Y, Wopereis H, Kakourou A, Liu M, Wu J, Li Z, Zhang L, Tan M, Low JSY, Liu M, Roeselers G, Knol J, Cai W. Restoration of gut microbiota with a specific synbiotic-containing infant formula in healthy Chinese infants born by cesarean section. Eur J Clin Nutr. 2025 Jun;79(6):567-575. doi: 10.1038/s41430-025-01571-8. Epub 2025 Feb 6.
- 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 New infant formula with synbiotics and Standard infant formula with prebiotics in people with Healthy Infants, 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 4 inclusion and 10 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 26 Feb 2021. 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?
Weight gain per day from baseline (g/day) (time frame: at the age of 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520764, which also lists 1 linked publication.
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 26 Feb 2021.